tri-council policy statement Ethical Conduct for Research ...The second edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans was launched in December

Ethical Conduct forResearch InvolvingHumans

Canadian Institutes of Health ResearchNatural Sciences and Engineering Research Council of CanadaSocial Sciences and Humanities Research Council of Canada

2014

t r i- cou nc i l pol ic y stat e m e n t

350 Albert Street Ottawa, ON Canada K1A 1H5 613-996-0072 [email protected] www.pre.ethics.gc.ca

On behalf of the: Canadian Institutes of Health Research: www.cihr-irsc.gc.caNatural Sciences and Engineering Research Council of Canada: www.nserc-crsng.gc.ca Social Sciences and Humanities Research Council of Canada: www.sshrc-crsh.gc.ca

Also available on the Web in PDF and HTML formats

© Her Majesty the Queen in Right of Canada (2014) Catalogue No: RR4-2/2014E-PDF ISBN 978-1-100-25473-9

TCPS2 2014

T R I - COU NC I L P O L I C Y STAT E M E N T

Ethical Conduct for Research Involving Humans 2014

Canadian Institutes of Health ResearchNatural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada

Please cite this document as follows:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada,and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: EthicalConduct for Research Involving Humans, December 2014.

Note: For the most recent information on amendments, please consult the official online version of theTCPS at www.pre.ethics.gc.ca.

Permission is granted to photocopy this material.

TCPS2 2014

T R I - COU NC I L P O L I C Y STAT E M E N T

Ethical Conduct for Research Involving Humans 2014

Canadian Institutes of Health ResearchNatural Sciences and Engineering Research Council of Canada Social Sciences and Humanities Research Council of Canada

Please cite this document as follows:

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada,and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: EthicalConduct for Research Involving Humans, December 2014.

Note: For the most recent information on amendments, please consult the official online version of theTCPS at www.pre.ethics.gc.ca.

Permission is granted to photocopy this material.

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Table of Contents

Acknowledgements ............................................................................................1INTRODUCTION ..................................................................................................3

Mandate of the Agencies ..............................................................................3Compliance with the Policy ...........................................................................3

Chapter 1 .........................................................................................................5ETHICS FRAMEWORK .......................................................................................5

A. Importance of Research and Research Ethics...............................................5B. Core Principles.......................................................................................6C. How to Apply This Policy .........................................................................9

Chapter 2........................................................................................................13SCOPE AND APPROACH ..................................................................................13

Introduction .............................................................................................13A. Scope of Research Ethics Review .............................................................13B. Approach to Research Ethics Board Review ...............................................20

Chapter 3........................................................................................................25THE CONSENT PROCESS..................................................................................25

Introduction .............................................................................................25A. General Principles.................................................................................26B. Departures from General Principles of Consent...........................................35C. Decision-Making Capacity ......................................................................42D. Consent Shall Be Documented.................................................................46

Chapter 4........................................................................................................49FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION........................................49

Introduction .............................................................................................49A. Appropriate Inclusion............................................................................50B. Inappropriate Exclusion .........................................................................50

Chapter 5........................................................................................................57PRIVACY AND CONFIDENTIALITY.....................................................................57

Introduction .............................................................................................57A. Key Concepts .......................................................................................57B. Ethical Duty of Confidentiality ................................................................60C. Safeguarding Information ......................................................................62D. Consent and Secondary Use of Identifiable Information for

Research Purposes ................................................................................64E. Data Linkage........................................................................................67

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Chapter 6........................................................................................................69GOVERNANCE OF RESEARCH ETHICS REVIEW ....................................................69

Introduction .............................................................................................69A. Establishment of Research Ethics Boards ..................................................69B. Procedures for Research Ethics Board Review ............................................78C. Reconsideration and Appeals ..................................................................86D. Research Ethics Review during Publicly Declared Emergencies ......................87

Chapter 7........................................................................................................93CONFLICTS OF INTEREST ................................................................................93

Introduction .............................................................................................93A. Key Concepts .......................................................................................93B. Institutions and Conflicts of Interest .......................................................95C. Research Ethics Board Members and Conflicts of Interest ............................97D. Researchers and Conflicts of Interest .......................................................98

Chapter 8 ......................................................................................................101MULTI-JURISDICTIONAL RESEARCH...............................................................101

Introduction ...........................................................................................101A. Review Mechanisms for Research Involving Multiple Institutions and/or

Multiple Research Ethics Boards ............................................................101B. Ethics Review of Research Conducted outside the Institution .....................105

Chapter 9 ......................................................................................................109RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS PEOPLES OF CANADA .........................................................................109

Introduction ...........................................................................................109A. Key Concepts and Definitions................................................................111B. Interpreting the Ethics Framework in Aboriginal Contexts..........................113C. Applying Provisions of This Policy in Aboriginal Contexts ..........................114

Chapter 10 ....................................................................................................139QUALITATIVE RESEARCH ..............................................................................139

Introduction ...........................................................................................139A. Nature of Qualitative Research ..............................................................139B. Research Ethics Review of Qualitative Research........................................142

Chapter 11 ....................................................................................................151CLINICAL TRIALS........................................................................................151

Introduction ...........................................................................................151A. Key Concepts .....................................................................................152B. Clinical Trial Design and Registration .....................................................154

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C. Assessing Safety and Minimizing Risk.....................................................161D. Financial Conflicts of Interest ...............................................................168E. Analysis and Dissemination of Clinical Trial Outcomes...............................169

Chapter 12 ....................................................................................................175HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO HUMAN REPRODUCTION.............................................................175

Introduction ...........................................................................................175A. Key Concepts .....................................................................................175B. Collection of Human Biological Materials ................................................177C. Consent and Secondary Use of Identifiable Human Biological

Materials for Research Purposes ............................................................178D. Storage and Banking of Human Biological Materials .................................181E. Research Involving Materials Related to Human Reproduction ....................183F. Research Involving Human Pluripotent Stem Cells ....................................185

Chapter 13 ....................................................................................................193HUMAN GENETIC RESEARCH .........................................................................193

Introduction ...........................................................................................193A. Application of Core Principles to Genetic Research ...................................193B. Plans for Managing Information Revealed through Genetic Research ...........194C. Genetic Counselling.............................................................................196D. Genetic Research Involving Families ......................................................196E. Genetic Research Involving Communities and Groups................................197F. Genetic Material Banks ........................................................................198G. Gene Transfer .....................................................................................198

Glossary ........................................................................................................201

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Acknowledgements

The second edition of the Tri-Council Policy Statement: Ethical Conduct for Research InvolvingHumans was launched in December 2010. TCPS 2, as it is commonly known, updated and ex-panded the original (1998) version of TCPS. The Panel on Research Ethics (PRE) and theSecretariat on Responsible Conduct of Research that supports PRE, strive to ensure that TCPS 2is current and that the guidance it provides is as clear as possible. In this, they have always receivedthe full support of the federal research agencies (CIHR, NSERC and SSHRC) that are jointly re-sponsible for the TCPS, and for PRE and the Secretariat.

This revised version of TCPS 2 reflects the efforts of PRE and the Secretariat since the launch ofTCPS 2 to achieve those goals. Together, they have addressed areas requiring clarification and re-sponded to the evolution of issues that arise in research involving humans. These efforts areinformed by the feedback we received from the research community and from those whose pro-fessional focus is research ethics. Community engagement provides an invaluable source ofinformation for PRE and the Secretariat, whether through our interpretation service, our speakingengagements at regional and national meetings, or our public consultation on the proposed changesthat led to this version of TCPS 2. It is our hope that these revisions make TCPS 2 a more usefulresource for researchers and, therefore, a more effective instrument for the protection of researchparticipants.

We would like to take this opportunity to thank our colleagues, past and present, on PRE, as wellas the staff of the Secretariat, for their commitment to ensuring that the ethics of human researchis integral to all research efforts. We would like to thank the members of CIHR’s Stem Cell Over-sight Committee (SCOC) for their assistance with the integration of the Guidelines for HumanPluripotent Stem Cell Research into TCPS 2. Thanks are also due to the members of the publicwho have generously shared their knowledge, experience and expertise to assist us in our ongoingcommitment to improve TCPS 2.

Respectfully submitted by:Samuel K. Ludwin Jim FrideresChair, Panel on Research Ethics Chair, Panel on Research Ethics(2010–2012) (2012–2015)

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Panel on Research Ethics

Judith Bartlett Michel Bergeron

Édith Deleury Anne Dooley Carolyn Ells Deborah Fels Lawrence Felt Pierrette Fortin

Lisa Given James Lavery

Patrick O’Neill Gordon Robinson Martin Schechter Veronica Stinson Lehana Thabane Brent Windwick

Secretariat on Responsible Conduct of Research

Susan Zimmerman, Executive DirectorHanan Abdel-Akher, Senior Policy Analyst

Laura-Lee Balkwill, Policy AnalystMargaret Blakeney, Senior Policy Analyst

Wendy Burgess, Policy AnalystSara Esam, Senior Policy Analyst

Nicki Jenish, Program and Administration Officer Susan Lalumiere, Program and Administration Officer

Heather Dana Munroe, Communications OfficerKaren Wallace, Senior Advisor

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INTRODUCTION

The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS or thePolicy) is a joint policy of Canada’s three federal research agencies – the Canadian Institutes ofHealth Research (CIHR), the Natural Sciences and Engineering Research Council of Canada(NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC), or “the Agencies.”

This Policy expresses the Agencies’ continuing commitment to the people of Canada to promotethe ethical conduct of research involving humans. It has been informed, in part, by leading inter-national ethics norms, all of which may help, in some measure, to guide Canadian researchers, inCanada and abroad, in the conduct of research involving humans.

This edition represents the first substantive change to the Policy since its adoption in 1998. It is amajor revision, reflecting over a decade of experience in the application of the Policy by the re-search community to existing and emerging ethical issues and new areas of research. It also distilsthe experience of the Interagency Advisory Panel on Research Ethics (PRE or the Panel), whichwas created in 2001 primarily to steward the evolution and interpretation of this Policy, and toprovide the Agencies with independent advice on issues related to the ethics of research involvinghumans. This edition, which replaces the original TCPS, draws on the advice provided to the Panelby its working groups and committees. As well, it reflects the significant and valuable input fromthe research community and all those who provided feedback on the drafts that the Panel circulatedpublicly in December 2008 and December 2009.

Mandate of the Agencies

The people of Canada, through Acts of Parliament,1 have created and funded the Agencies topromote and assist research within their respective legislative mandates. In discharging theirmandates, the Agencies wish to promote research that is conducted according to the highest ethicalstandards. The Agencies have therefore adopted this Policy as a benchmark for the ethical conductof research involving humans. As a condition of funding, the Agencies require that researchersand their institutions apply the ethical principles and the articles of this Policy and be guided bythe application sections of the articles.

Compliance with the Policy

To be eligible to receive and administer research funds from the Agencies, institutions must agreeto comply with a number of Agency policies set out as schedules to an Agreement between theAgencies and institutions.2 This Policy is referenced in Schedule 2 to that Agreement. Institutionsmust therefore ensure that research conducted under their auspices adhere to this Policy. Re-searchers are expected, as a condition of funding, to adhere to the TCPS. Institutions should supporttheir efforts to do so.

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In addition to this Policy on the ethics of research involving humans, institutions and theirresearchers must adhere to the other policies referenced in the Agreement, which include policieson research integrity, peer review and conflicts of interest in research.3

Organizations and entities not party to the Agreement are welcome to adopt this Policy to guidethe ethical aspects of the design, review and conduct of research involving humans. Since theadoption of the original Policy in 1998, many bodies in Canada and abroad have adopted, adaptedand been guided by this document. The Agencies hope that this Policy will continue to serve as amodel and guide for the ethical conduct of research involving humans.

The Agencies recognize that considerations around the ethical conduct of research involvinghumans are complex and continually evolving. We therefore welcome comments and discussion,and commit to the continued evolution of this document.

The online version of the Policy, which will include all updates and revisions, shall be consideredthe official version.

Endnotes

1 See Canadian Institutes of Health Research Act, Statutes of Canada, 2000, Chapter 6; Natural Sciencesand Engineering Research Council Act, Revised Statutes of Canada, 1985, Chapter N-21; SocialSciences and Humanities Research Council Act, Revised Statutes of Canada, 1985, Chapter S-12.

2 Agreement on the Administration of Agency Grants and Awards by Research Institutions.

3 Schedules 4 (research integrity), 6 (peer review) and 14 (conflicts of interest).

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5TCPS 2 (2014)

Chapter 1ETHICS FRAMEWORK

A. Importance of Research and Research Ethics

The search for knowledge about ourselves and the world around us is a fundamental humanendeavour. Research is a natural extension of this desire to understand and to improve the worldin which we live.

The scope of research is vast. On the purely physical side, it ranges from seeking to understandthe origins of the universe down to the fundamental nature of matter. At the analytic level, it coversmathematics, logic and metaphysics. Research involving humans ranges widely, including attemptsto understand the broad sweep of history, the workings of the human body and the body politic,the nature of human interactions and the impact of nature on humans – the list is as boundless asthe human imagination. For the purposes of this Policy, research is defined as an undertakingintended to extend knowledge through a disciplined inquiry and/or systematic investigation.

There can be no doubt that research has greatly enriched and improved our lives. Significantadvances in human understanding in the social sciences, humanities, natural sciences, engineeringand health sciences have been made as a result of research involving humans. A fundamentalpremise of this Policy is that research can benefit human society. In order to maximize the benefitsof research, researchers must have academic freedom. Academic freedom includes freedom ofinquiry, the right to disseminate the results of that inquiry, freedom to challenge conventionalthought, freedom to express one’s opinion about the institution, its administration or the systemin which one works, and freedom from institutional censorship. With academic freedom comesresponsibility, including the responsibility to ensure that research involving humans meets highscientific and ethical standards that respect and protect the participants. Thus, researchers’commitment to the advancement of knowledge also implies duties of honest and thoughtful inquiry,rigorous analysis, commitment to the dissemination of research results, and adherence to the useof professional standards. There is a corresponding responsibility on the part of institutions todefend researchers in their efforts to uphold academic freedom and high ethical, scientific andprofessional standards.

Research is a step into the unknown. Because it seeks to understand something not yet revealed,research often entails risks to participants and others. These risks can be trivial or profound,physical or psychological, individual or social. History offers unfortunate examples where researchparticipants have been needlessly, and at times profoundly, harmed by research, sometimes evendying as a result. Ethical principles and guidelines play an important role in advancing the pursuitof knowledge while protecting and respecting research participants in order to try to prevent suchoccurrences.

People have also been gratified and have had their lives enriched by their participation in research,either because they may have benefited directly or because their participation has contributed to


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Chapter 1 – Ethics Framework

the expansion of knowledge. Given the fundamental importance of research and of human partic-ipation in research, we must do all that we can as a society to ensure that research is conducted inan ethical manner so as to build public confidence and trust. By promoting and guiding the ethicalconduct of research involving humans, this Policy seeks to contribute tangibly to these goals.

No single document can provide definitive answers to all ethical issues that may arise in anundertaking as complex as research involving humans. This Policy aims to assist those who use it– researchers, sponsors, members of research ethics boards (REBs), participants, and the public –to identify ethical issues in the design, conduct and oversight of research and to point the way toarriving at reasoned and ethical responses to these issues.

B. Core Principles

Respect for human dignity has been an underlying value of the Tri-Council Policy Statement: Eth-ical Conduct for Research Involving Humans (TCPS or the Policy) since its inception. Despiteclear recognition of its centrality in research ethics, the term lends itself to a variety of definitionsand interpretations that make it challenging to apply.

Respect for human dignity requires that research involving humans be conducted in a manner thatis sensitive to the inherent worth of all human beings and the respect and consideration that theyare due. In this Policy, respect for human dignity is expressed through three core principles – Re-spect for Persons, Concern for Welfare, and Justice. These core principles transcend disciplinaryboundaries and, therefore, are relevant to the full range of research covered by this Policy.1

Article 1.1 The guidelines in this Policy are based on the following three core principles:• Respect for Persons• Concern for Welfare• Justice

These principles are complementary and interdependent. How they apply and the weight accordedto each will depend on the nature and context of the research being undertaken. Specific applica-tions are addressed in the following chapters.

Respect for Persons

Respect for Persons recognizes the intrinsic value of human beings and the respect and consider-ation that they are due. It encompasses the treatment of persons involved in research directly asparticipants and those who are participants because their data or human biological materials, whichfor the purposes of this Policy include materials related to human reproduction, are used in re-search. Respect for Persons incorporates the dual moral obligations to respect autonomy and toprotect those with developing, impaired or diminished autonomy.

Autonomy includes the ability to deliberate about a decision and to act based on that deliberation.Respecting autonomy means giving due deference to a person’s judgment and ensuring that theperson is free to choose without interference. Autonomy is not exercised in isolation but isinfluenced by a person’s various connections to family, to community, and to cultural, social,linguistic, religious and other groups. Likewise, a person’s decisions can have an impact on anyof these connections.


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An important mechanism for respecting participants’ autonomy in research is the requirement toseek their free, informed and ongoing consent. This requirement reflects the commitment that par-ticipation in research, including participation through the use of one’s data or biological materials,should be a matter of choice and that, to be meaningful, the choice must be informed. An informedchoice is one that is based on as complete an understanding as is reasonably possible of the purposeof the research, what it entails, and its foreseeable risks and potential benefits, both to the partic-ipant and to others. Respect for Persons also includes a commitment to accountability andtransparency in the ethical conduct of research.

Certain factors may diminish a person’s ability to exercise their autonomy, such as inadequateinformation or understanding for deliberation, or a lack of freedom to act due to controllinginfluences or coercion. Such constraints may include the fear of alienating those in positions ofauthority, such as professional or personal caregivers, researchers, leaders, larger groups, or acommunity to which one belongs. Other constraints may consist of barriers to accessing resourcesor knowledge outside the research context. These factors and constraints should be addressed priorto any research being carried out, so as to ensure participants are sufficiently protected.

Some people may be incapable of exercising autonomy because of youth, cognitive impairment,other mental health issues or illness. While autonomy may be considered a necessary conditionfor participation in research, involving those who lack capacity to make their own decisions toparticipate can be valuable, just and even necessary. For those prospective participants, additionalmeasures are needed to protect their interests and to ensure that their wishes (to the extent thatthese are known) are respected. These measures will generally include seeking consent from anauthorized third party who is entrusted to make decisions on behalf of the prospective participant,based on knowledge of that person and that person’s wishes or, if such wishes are unknown, onconsideration of that person’s welfare. Even when the requirements of free, informed and ongoingconsent cannot be met, Respect for Persons requires involving individuals in circumstances ofvulnerability in decision making where possible. This may include asking about their feelingsregarding participation and/or for their assent.

Where it is foreseeable that a participant may lose decision-making capacity during a researchproject, for example in studies of cognitive impairment, it may be appropriate to ask participantsto express their preferences and ensure that they have authorized a trusted person to make decisionson their behalf should they lose the capacity to decide whether or not to continue their researchparticipation (see Article 3.11 for guidance on research directives for individuals who lackdecision-making capacity).

Concern for Welfare

The welfare of a person is the quality of that person’s experience of life in all its aspects. Welfareconsists of the impact on individuals of factors such as their physical, mental and spiritual health,as well as their physical, economic and social circumstances. Thus, determinants of welfare caninclude housing, employment, security, family life, community membership, and socialparticipation, among other aspects of life. Other contributing factors to welfare are privacy andthe control of information about the person, and the treatment of human biological materialsaccording to the free, informed and ongoing consent of the person who was the source of the


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information or materials. A person’s or group’s welfare is also affected by the welfare of thosewho are important to them. Harm includes any negative effects on welfare, broadly construed (forthe relationship between risk and harm, see Chapter 2, Section B). Note that, for the purposes ofthis Policy, “group” and “community” are used in their ordinary sense. More detailed types ofcommunity as defined in Chapter 9 are specific to Aboriginal contexts.

Concern for Welfare means that researchers and REBs should aim to protect the welfare ofparticipants, and, in some circumstances, to promote that welfare in view of any foreseeable risksassociated with the research. They are to provide participants with enough information to be ableto adequately assess risks and potential benefits associated with their participation in the research.To do so, researchers and REBs must ensure that participants are not exposed to unnecessary risks.Researchers and REBs must attempt to minimize the risks associated with answering any givenresearch question. They should attempt to achieve the most favourable balance of risks andpotential benefits in a research proposal. Then, in keeping with the principle of Respect for Persons,participants or authorized third parties, make the final judgment about the acceptability of thisbalance to them.

The welfare of groups can also be affected by research. Groups may benefit from the knowledgegained from the research, but they may also suffer from stigmatization, discrimination or damageto reputation. Engagement during the design process with groups whose welfare may be affectedby the research can help to clarify the potential impact of the research and indicate where any neg-ative impact on welfare can be minimized. Researchers must also consider the risks and potentialbenefits of their research and the knowledge it might generate for the welfare of society as a whole.Where research on individuals may affect the welfare of a group(s), the weight given to the group’swelfare will depend on the nature of the research being undertaken, and the individuals or groupin question. This consideration does not imply, however, that the welfare of a group should begiven priority over the welfare of individuals.

Justice

Justice refers to the obligation to treat people fairly and equitably. Fairness entails treating allpeople with equal respect and concern. Equity requires distributing the benefits and burdens ofresearch participation in such a way that no segment of the population is unduly burdened by theharms of research or denied the benefits of the knowledge generated from it.

Treating people fairly and equitably does not always mean treating people in the same way. Dif-ferences in treatment or distribution are justified when failures to take differences into accountmay result in the creation or reinforcement of inequities. One important difference that must beconsidered for fairness and equity is vulnerability. Vulnerability is often caused by limited deci-sion-making capacity, or limited access to social goods, such as rights, opportunities and power.Individuals or groups in vulnerable circumstances have historically included children, the elderly,women, prisoners, those with mental health issues and those with diminished capacity for self-determination. Ethnocultural minorities and those who are institutionalized are other examples ofgroups who have, at times, been treated unfairly and inequitably in research, or have been excludedfrom research opportunities. People or groups whose circumstances cause them to be vulnerableor marginalized may need to be afforded special attention in order to be treated justly in research.


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The recruitment process, both of participants who may become directly involved in research andthose who participate as the source of information or biological materials to be used in research,is an important component of the fair and equitable conduct of research. Participation should bebased on inclusion criteria that are justified by the research question. Inequity is created when par-ticular groups fail to receive fair benefits of research or when groups, or their data or theirbiological materials, are excluded from research arbitrarily or for reasons unrelated to the researchquestion.

An important threat to Justice is the imbalance of power that may exist in the relationship betweenresearcher and participant. Participants will generally not understand the research in the same wayand in the same depth as does the researcher. Historically, there have been instances in which thispower imbalance has been abused, with resulting harm to participants.

The Core Principles – Conclusion

The importance of research and the need to ensure the ethical conduct of research requires bothresearchers and REB members to navigate a sometimes difficult course between the two maingoals of providing the necessary protection of participants and serving the legitimate requirementsof research. The three core principles that express the value of human dignity provide the compassfor that journey. Their application will help ensure that a balance between these two goals is main-tained. Applying the core principles will also maintain free, informed and ongoing consentthroughout the research process and lead to sharing the benefits of the research. These results willhelp to build and maintain the trust of participants and the public in the research process.

C. How to Apply This Policy

Proportionate Approach to REB Review

This Policy aims to strike an appropriate balance between recognition of the potential benefits ofresearch, and protection of participants from research-related harms, including injustices andbreaches of Respect for Persons. Given that research involving humans spans the full spectrum ofrisk, from minimal to significant, a crucial element of REB review is to ensure that the level ofscrutiny of a research project is determined by the level of risk it poses to participants (see Article6.12). A reduced level of scrutiny applied to a research project assessed as minimal risk does notimply a lower level of adherence to the core principles. Rather, the intention is to ensure adequateprotection of participants is maintained while reducing unnecessary impediments to, and facili-tating the progress of, ethical research. This approach is in keeping with the need to respectacademic freedom and not to place unwarranted constraints upon it.

In the context of both initial and continuing research ethics review, the REB assesses the ethicalacceptability of a research project through consideration of the foreseeable risks, the potentialbenefits and the ethical implications of the project (see Article 2.9). These two steps constitute theproportionate approach to REB review that is recommended throughout the Policy.


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Research Ethics and Law

In addition to the principles and guidelines in this Policy, researchers are responsible forascertaining and complying with all applicable legal and regulatory requirements with respect toconsent and the protection of privacy of participants (see Chapter 5). These legal and regulatoryrequirements may vary depending on the jurisdiction in Canada in which the research is beingconducted, and who is funding and/or conducting the research, and they may compriseconstitutional, statutory, regulatory, common law, and/or international or legal requirements ofjurisdictions outside of Canada. Where the research is considered to be a governmental activity,for example, standards for protecting privacy flowing from the Canadian Charter of Rights andFreedoms, federal privacy legislation and regulatory requirements would apply.

The law affects and regulates the standards and conduct of research involving humans in a varietyof areas, including, but not limited to privacy, confidentiality, intellectual property and the decision-making capacity of participants. In addition, human rights legislation and most documents onresearch ethics prohibit discrimination on a variety of grounds and recognize equal treatment asfundamental. REBs and researchers should also respect the spirit of the Canadian Charter ofRights and Freedoms, particularly the sections dealing with life, liberty and security of the person,as well as those involving equality and discrimination.

Researchers may face situations where they experience a tension between the requirements of thelaw and the guidance of the ethical principles in this Policy. In such situations, researchers shouldstrive to comply with the law in the application of ethical principles. Researchers should consultwith colleagues, the REB or any relevant professional body, and if necessary, seek independentlegal advice to help resolve any conflicts between law and ethics, and guide an appropriate courseof action.

This legal context for research involving humans is constantly evolving and varies from jurisdictionto jurisdiction. For this reason, REBs and researchers should be aware of applicable laws so theycan identify legal issues that may occur in the conduct of research. REBs may satisfy this obligationthrough expertise among their members or through wider consultation. The researcher may seekindependent legal advice when necessary.

The Perspective of the Participant

In designing and conducting research or reviewing the ethics of research, researchers and REBsmust be mindful of the perspective of the participant. It may be necessary to consider the variouscontexts (e.g., social, economic, cultural) that shape the participant’s life, to properly evaluate theimplications of the research in terms of the core principles.

Appropriate Expertise for Review

It is also important that research ethics review be appropriate to the disciplines, fields of research,and methods of the research being reviewed. This means that REBs must understand the disciplineand method under review and be able to assess the research on its own terms. This Policy providesmore direction concerning appropriate expertise in Articles 6.4 and 6.5.


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Interpreting This Policy

This Policy contains both guidance for the interpretation of the principles of research ethics, aswell as a number of mandatory requirements for researchers, institutions and members of REBs.Mandatory provisions are signalled by the use of the term “shall.” Guidance for the interpretationof the core principles is generally indicated by use of the term “should.”

Evaluating the ethics of research involving humans is not, and cannot be, an exact science. Theinterpretation and application of the articles and principles to particular circumstances will alwaysbe a part of the exercise. The articles in this Policy are intended to provide guidance, and in somecases, to set out certain requirements. The application sections are intended to supplement thearticles with further explanation and examples. Although they cannot guarantee identical decisionsacross REBs, they can ensure that researchers and REBs employing this Policy are operating withinthe same parameters and taking into account the same considerations as they design and evaluateresearch involving humans.

At the end of some chapters, a section entitled “References” provides links to documents thatcontain further guidance on specific topics addressed in the chapter. These references are not meantto be exhaustive, but are offered to assist the reader who wishes to explore certain topics in greaterdetail.

This Policy will continue to evolve in response to the emerging needs and suggestions of all thosewhom this Policy is intended to serve, including the research community, participants and thepublic.

Definitions

The definitions provided in this Policy are intended specifically and solely for the purposes of thisPolicy.

Endnote

1 The three core principles incorporate within them the eight guiding ethical principles set out in the1998 TCPS. Respect for Human Dignity is expressed through the three core principles. Respect for Freeand Informed Consent and Respect for Vulnerable Persons are both reflected in the principle of Respectfor Persons, while Respect for Vulnerable Persons is also reflected in the principle of Justice. Respect forPrivacy and Confidentiality is an element of Concern for Welfare. Respect for Justice and Inclusivenessis covered in the core principle of Justice. Balancing Harms and Benefits, Minimizing Harm andMaximizing Benefit are, in fact, not principles, but are the means by which the principle of Concern forWelfare is put into effect. Each of these elements is addressed in greater detail in a chapter or section ofthis Policy.

By using these broader and more encompassing core principles, this Policy seeks to provide a morefocused framework for the ethical guidance that follows. It is also a framework that harmonizes withother national and international ethics policies.



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Chapter 2SCOPE AND APPROACH

Introduction

The purpose of this Policy, as set out in Chapter 1, is to establish principles to guide the design,ethical conduct and ethics review process of research involving humans. This chapter outlines thescope of application of the Policy and the approach to research ethics review that flows from thecore principles – Respect for Persons, Concern for Welfare, and Justice. The preferred approachto research ethics review is a proportionate approach. The research ethics board (REB) tailors thelevel of scrutiny by an REB to the level of risk presented by the research, and assesses the ethicalacceptability of the research through consideration of the foreseeable risks, the potential benefitsand the ethical implications of the research, both at the stage of the initial REB review andthroughout the life of the project (continuing ethics review). The establishment, governance,jurisdiction and composition of REBs, and operational issues related to their functioning areaddressed in Chapter 6.

A. Scope of Research Ethics Review

Research Requiring REB Review

The following article defines the general categories of research that require REB review inaccordance with this Policy, subject to the exceptions set out further on in this Policy. Theseexceptions are distinct from research that is exempt from REB review, as described in Articles 2.2to 2.4.

Article 2.1 The following requires ethics review and approval by an REB before the researchcommences:

(a) research involving living human participants;

(b) research involving human biological materials, as well as human embryos,fetuses, fetal tissue, reproductive materials and stem cells. This applies tomaterials derived from living and deceased individuals.

Application The scope of this Policy is restricted to the review of the ethical conduct of researchinvolving humans. The scope of REB review is limited to those activities definedin this Policy as “research” involving “human participants.”

For the purposes of this Policy, “research” is defined as an undertaking intended toextend knowledge through a disciplined inquiry and/or systematic investigation.The term “disciplined inquiry” refers to an inquiry that is conducted with the ex-pectation that the method, results, and conclusions will be able to withstand the


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Chapter 2 – Scope and Approach

scrutiny of the relevant research community. For example, a study seeking to ex-plore the narratives of teens coping with mental illness would be evaluated by theestablished standards of studies employing similar methods, technologies and/ortheoretical frameworks.

A determination that research is the intended purpose of the undertaking is key fordifferentiating activities that require ethics review by an REB and those that do not(see Article 2.5). In some cases it can be difficult to make this distinction, under-scoring the need to have reviewers or ad hoc advisors (see Articles 6.4 and 6.5)who can assist with this determination. It is important to note that choice of method-ology and/or intent or ability to publish findings are not factors that determinewhether or not an activity is research requiring ethics review.

For the purposes of this Policy, “human participants” (referred to as “participants”)are those individuals whose data, or responses to interventions, stimuli or questionsby the researcher, are relevant to answering the research question.

Human participants are unique among the many parties involved in research,because they bear the primary risks of the research. These individuals are oftenreferred to as “research subjects.” This Policy prefers the term “participant” becauseit better reflects the spirit behind the core principles: that individuals who chooseto participate in research play a more active role than the term “subject” conveys.As well, it reflects the range of research covered by this Policy, and the varieddegree of involvement by participants – including the use of their data or humanbiological materials – that different types of research offer. The core principles ofthis Policy – Respect for Persons, Concern for Welfare, and Justice – help to shapethe relationship between researchers and participants.

Where researchers seek to collect, use, share and access different types ofinformation or data about participants, they are expected to determine whether theinformation or data proposed in research may reasonably be expected to identifyan individual. For the purposes of this Policy, researchers and REBs shall considerwhether information is identifiable or non-identifiable. Information is identifiableif it may reasonably be expected to identify an individual, when used alone orcombined with other available information. Information is non-identifiable if itdoes not identify an individual, for all practical purposes, when used alone orcombined with other available information. The term “personal information”generally denotes identifiable information about an individual. The assessment ofwhether information is identifiable is made in the context of a specific researchproject. Guidance on the assessment of the potential for information to identify anindividual is addressed in this Policy in Chapter 5, Section A.

In some cases, research may involve interaction with individuals who are notthemselves the focus of the research in order to obtain information. For example,one may collect information from authorized personnel to release information ordata in the ordinary course of their employment about organizations, policies,


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procedures, professional practices or statistical reports. Such individuals are notconsidered participants for the purposes of this Policy. This is distinct fromsituations where individuals are considered participants because they arethemselves the focus of the research. For example, individuals who are asked fortheir personal opinions about organizations, or who are observed in their worksetting for the purposes of research, are considered participants.

For the purposes of this Policy, human biological materials include tissues, organs,blood, plasma, serum, DNA, RNA, proteins, cells, skin, hair, nail clippings, urine,saliva and other body fluids. Materials related to human reproduction includeembryos, fetuses, fetal tissues and human reproductive materials. Embryo meansa human organism during the first 56 days of its development following fertilizationor creation, excluding any time during which its development has been suspended,and includes any cell derived from such an organism that is used for the purposeof creating a human being. Fetus means a human organism during the period of itsdevelopment beginning on the 57th day following fertilization or creation, excludingany time during which its development has been suspended, and ending at birth.Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and othertissue that contains genetic information about the fetus. Human reproductivematerials mean a sperm, ovum or other human cell, or a human gene, as well as apart of any of them. The term “human biological materials” may be considered,for the purposes of this Policy, to include materials related to human reproduction.The last section of Chapter 12 discusses ethical issues specific to these materials.1

When in doubt about the applicability of this Policy to a particular research project,the researcher shall seek the opinion of the REB. The REB makes the final decisionon exemption from research ethics review.

Research Exempt from REB Review

Some research is exempt from REB review where protections are available by other means. ThisPolicy allows the following exemptions from the requirement for REB review, as outlined below.

Article 2.2 Research that relies exclusively on publicly available information does not requireREB review when:

(a) the information is legally accessible to the public and appropriately protectedby law; or

(b) the information is publicly accessible and there is no reasonable expectation ofprivacy.

Application For the purposes of this Policy, publicly available information is any existing storeddocumentary material, records or publications, which may or may not includeidentifiable information. Some types of information are legally accessible to thepublic in a certain form and for a certain purpose, as specified by law or regulations:registries of deaths, court judgments, or public archives and publicly available


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statistics (e.g., Statistics Canada public use files), for example. In Canada, allpublicly available archives (national, provincial or municipal) have policiesgoverning access to their records. An archival record or database that is subject torestrictions, such as those under access to information and privacy legislation orcontractual restrictions imposed by the donor of the records, may also be consideredpublicly available for the purposes of this Policy.

Research that relies exclusively on information that is publicly available, or madeaccessible through legislation or regulation, does not require REB review.Exemption from REB review for research involving information that is legallyaccessible to the public is based on the presence of a legally designatedcustodian/steward who protects its privacy and proprietary interests (e.g., an accessto information and privacy coordinator or a guardian of Canadian census data).

REB review is also not required where research uses exclusively publicly availableinformation that may contain identifiable information, and for which there is noreasonable expectation of privacy. For example, identifiable information may bedisseminated in the public domain through print or electronic publications; film,audio or digital recordings; press accounts; official publications of private or publicinstitutions; artistic installations, exhibitions or literary events freely open to thepublic; or publications accessible in public libraries. Research that is non-intrusive,and does not involve direct interaction between the researcher and individualsthrough the Internet, also does not require REB review. Cyber-material such asdocuments, records, performances, online archival materials or published thirdparty interviews to which the public is given uncontrolled access on the Internetfor which there is no expectation of privacy is considered to be publicly availableinformation.

Exemption from REB review is based on the information being accessible in thepublic domain, and that the individuals to whom the information refers have noreasonable expectation of privacy. Information contained in publicly accessiblematerial may, however, be subject to copyright and/or intellectual property rightsprotections or dissemination restrictions imposed by the legal entity controlling theinformation.

However, there are situations where REB review is required.

There are publicly accessible digital sites where there is a reasonable expectationof privacy. When accessing identifiable information in publicly accessible digitalsites, such as Internet chat rooms, and self-help groups with restricted membership,the privacy expectation of contributors of these sites is much higher. Researchersshall submit their proposal for REB review (see Article 10.3).

Where data linkage of different sources of publicly available information isinvolved, it could give rise to new forms of identifiable information that wouldraise issues of privacy and confidentiality when used in research, and wouldtherefore require REB review (see Article 5.7).


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When in doubt about the applicability of this article to their research, researchersshould consult their REBs.

Article 2.3 REB review is not required for research involving the observation of people inpublic places where:

(a) it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;

(b) individuals or groups targeted for observation have no reasonable expectation of privacy; and

(c) any dissemination of research results does not allow identification of specific individuals.

Application For the purposes of this article, observational research is used to study acts orbehaviour in a natural environment. It does not refer to observational methods usedin epidemiological studies.

When designing their research, researchers shall pay attention to the environmentin which observation takes place, the expectation of privacy that individuals inpublic places might have, and the means of recording observations. Researchersshall also determine whether the use of this information in the dissemination ofresearch results (e.g., through publications, photographs, audio recordings, or videofootage of groups or particular individuals) will allow the identification ofindividuals observed in public places. When in doubt, researchers should consultthe REB prior to the conduct of such research. Article 10.3 addresses observationalstudies in qualitative research.

Article 2.4 REB review is not required for research that relies exclusively on secondary useof anonymous information, or anonymous human biological materials, so long asthe process of data linkage or recording or dissemination of results does notgenerate identifiable information.

Application Secondary use refers to the use in research of information or human biologicalmaterials originally collected for a purpose other than the current research purpose.Anonymous information and human biological materials are distinct from thosethat have been coded, and also from those that have been anonymized (see SectionA of Chapters 5 and 12).

Rapid technological advances facilitate identification of information and make itharder to achieve anonymity. These activities may heighten risks of identificationand possible stigmatization where a dataset contains information about or humanbiological materials from a population in a small geographical area, or informationabout individuals with unique characteristics (e.g., uncommon field of occupationalspecialization, diagnosis with a very rare disease). Where the researcher seeks datalinkage of two or more anonymous sets of information or human biological


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materials and there is a reasonable prospect that this could generate identifiableinformation, then REB review is required.

Guidance related to other categories of identifiable and non-identifiable informationand human biological materials and their possible secondary use is provided inChapters 5 and 12.

Activities Not Requiring REB Review

The following distinguishes research requiring REB review from non-research activities that havetraditionally employed methods and techniques similar to those employed in research. Suchactivities are not considered “research” as defined in this Policy, and do not require REB review.Activities outside the scope of research subject to REB review (see Articles 2.5 and 2.6), as definedin this Policy, may still raise ethical issues that would benefit from careful consideration by anindividual or a body capable of providing some independent guidance, other than an REB. Theseethics resources may be based in professional or disciplinary associations, particularly where thoseassociations have established best practices guidelines for such activities in their discipline.

Article 2.5 Quality assurance and quality improvement studies, program evaluation activities,and performance reviews, or testing within normal educational requirements whenused exclusively for assessment, management or improvement purposes, do notconstitute research for the purposes of this Policy, and do not fall within the scopeof REB review.

Application Article 2.5 refers to assessments of the performance of an organization or itsemployees or students, within the mandate of the organization, or according to theterms and conditions of employment or training. Those activities are normallyadministered in the ordinary course of the operation of an organization whereparticipation is required, for example, as a condition of employment in the case ofstaff performance reviews, or an evaluation in the course of academic orprofessional training. Other examples include student course evaluations, or datacollection for internal or external organizational reports. Such activities do notnormally follow the consent procedures outlined in this Policy.

If data are collected for the purposes of such activities but later proposed forresearch purposes, it would be considered secondary use of information notoriginally intended for research, and at that time may require REB review inaccordance with this Policy. Refer to Section D of Chapter 5 for guidanceconcerning secondary use of identifiable information for research purposes.

Article 2.6 Creative practice activities, in and of themselves, do not require REB review.However, research that employs creative practice to obtain responses from partic-ipants that will be analyzed to answer a research question is subject to REB review.

Application Creative practice is a process through which an artist makes or interprets a workor works of art. It may also include a study of the process of how a work of art is


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generated. Creative practice activities do not require REB review, but they may begoverned by ethical practices established within the cultural sector.

Relationship between Research Ethics Review and Scholarly Review

Article 2.7 As part of research ethics review, the REB shall review the ethical implications ofthe methods and design of the research.

Application The primary test to be used by REBs in evaluating a research project should beethical acceptability and, where appropriate, relevant disciplinary scholarlystandards.

Traditions for scholarly review vary among disciplines or fields of research,including the stage at which scholarly review occurs, and this needs to be takeninto account by REBs. The extent of the scholarly review that is required forbiomedical research that does not involve more than minimal risk will varyaccording to the research being carried out. Research in the humanities and thesocial sciences that poses, at most, minimal risk shall not normally be required bythe REB to be peer reviewed.

REBs should normally avoid duplicating previous professional peer-reviewassessments unless there is a good and defined reason to do so. It is to be notedthat for specific types of research (e.g., clinical trials) REBs should respect therelevant guidelines2 that require REBs to evaluate the scientific aspects of theresearch as part of their research ethics review.

Researchers have a role to play in demonstrating to their REB whether, when andhow appropriate scholarly review has been or will be undertaken for their research.REBs may request that the researcher provide them with the full documentation ofscholarly reviews already completed.

Where scholarly review is required,

• an REB should consider what scholarly review has been applied to a particularresearch project (e.g., by a funder or sponsor, or for student research by theresearch supervisor or thesis committee, or by a permanent peer reviewcommittee where it exists);

• if scholarly review as indicated by the relevant disciplinary tradition has not yetbeen done, and there is no body available to do it, the REB should consider thefollowing mechanisms in satisfying itself that scholarly review of the researchis completed:

- establish an ad hoc independent peer review committee;

- if the REB has the necessary scholarly expertise, assume completeresponsibility for the scholarly review. In assuming this responsibility, theREB should not be driven by factors such as personal biases or preferences,


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and should not reject proposals because they are controversial, challengemainstream thought, or offend powerful or vocal interest groups.

REB Review Shall Be Continuing

Article 2.8 Following initial REB review and approval, research ethics review shall continuethroughout the life of the project in accordance with Article 6.14.

Application The primary goal of REB review is to ensure the ethical acceptability of researchinvolving humans that falls within the scope of this Policy. Following the initialREB review and approval, the ethics review shall continue to ensure that all stagesof a research project are ethically acceptable in accordance with the principles ofthis Policy.

Continuing ethics review by an REB provides those involved in the researchprocess (in particular, researchers and REBs) with multiple opportunities to reflecton the ethical issues surrounding the research. This reflection can show whetherthe stated risks, or other unknown risks, were incurred and how they affected theindividual and collective welfare of participants. This reflective practice is intendedto enable both researchers and REBs to be more effective in protecting participantsin current and future research. This practice is especially important in new andemerging fields, where the ethical implications are not yet well understood. Here,reflection should involve an ongoing dialogue among REBs and researchers, asappropriate, to enable the practices surrounding research ethics to evolve as neededto comply with the principles of this Policy.

In the conduct of their approved research, should unanticipated issues arise thatmay increase the level of risk or have other ethical implications, researchers shallreport them to their REB in a timely manner. Researchers shall also submit to theirREBs in a timely manner requests for changes to their approved research. Furtherdetails are provided in Articles 6.14 to 6.16.

B. Approach to REB Review

This section introduces the concepts of risks and potential benefits of research (including adefinition of minimal risk), as well as their balance in research ethics review and the conduct ofresearch. It describes the proportionate approach to REB review: The REB tailors its level ofscrutiny to the level of risk presented by the research, and assesses the ethical acceptability of theresearch through consideration of the foreseeable risks, the potential benefits and the ethicalimplications of the research, both at the stage of the initial review and throughout the life of theproject (continuing ethics review).

Concepts of Risks and Potential Benefits

Potential Benefits

Research involving humans may produce benefits that positively affect the welfare of society as awhole through the advancement of knowledge for future generations, for participants themselves


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or for other individuals. However, much research offers little or no direct benefit to participants. Inmost research, the primary benefits produced are for society and for the advancement of knowledge.

Risks

Because research is a step into the unknown, its undertaking can involve harms to participantsand to others. Harm is anything that has a negative effect on the welfare of participants, and thenature of the harm may be social, behavioural, psychological, physical or economic.

Risk is a function of the magnitude or seriousness of the harm, and the probability that it willoccur, whether to participants or to third parties (as outlined below). A proper ethical analysis ofresearch should consider both the foreseeable risk and the available methods of eliminating ormitigating the risk.

• The magnitude or seriousness of the harm

Potential harms in research may span the spectrum from minimal (e.g., inconvenience ofparticipation in research) to substantial (e.g., a major physical injury or an emotional trauma).Harms may be transient, such as a temporary emotional reaction to a survey question, whileother types of harm may be longer lasting, such as the loss of reputation following a breachof confidentiality, or a traumatic experience. The perspective of the participants regardingharm may vary from that of researchers. Participants themselves may vary in their reactionto the research. Researchers and REBs should attempt to assess the harm from the perspectiveof the participants to the extent possible. Research in certain disciplines, such asepidemiology, genetics, sociology or cultural anthropology, may present risks that go beyondthe individual and may involve the interests of communities, societies or other definedgroups.

• The probability of occurrence of the harm

This refers to the likelihood of participants actually suffering the relevant harms. Anassessment of such probability may be based on the researcher’s past experience conductingsuch studies, the review of existing publications that provide rates of the relevant harms insimilar issues, or on other empirical evidence. And while researchers should attempt toestimate the occurrence of the relevant harms, this may be more difficult, or not possible,for new or emerging areas of research where no prior experience, comparable research orpublications exist.

Certain accepted research paradigms bring inherent limitations to the prior identification of risk.For example, when research in the social sciences employs emergent design, the manner in whichthe research project will proceed and any associated risks may be known only as it unfolds (seeChapters 3 and 10).

Minimal Risk

Minimal risk research that falls within the scope of this Policy requires REB review. It is generallyeligible for delegated review – described in Article 6.12.


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For the purposes of this Policy, “minimal risk” research is defined as research in which theprobability and magnitude of possible harms implied by participation in the research is no greaterthan those encountered by participants in those aspects of their everyday life that relate to theresearch.

In their assessment of the acceptable threshold of minimal risk, REBs have special ethicalobligations to individuals or groups whose situation or circumstances make them vulnerable inthe context of a specific research project, and to those who live with relatively high levels of risk ona daily basis. Their inclusion in research should not exacerbate their vulnerability (see Article 4.7).

Balancing Risks and Potential Benefits

The analysis, balance, and distribution of risks and potential benefits are critical to the ethics ofresearch involving humans. The principle of Concern for Welfare imposes an ethical obligation todesign, assess and conduct research in a way that protects participants from any unnecessary oravoidable risks. In their review, REBs should be concerned with an assessment that the potentialresearch outcomes and potential benefits merit the risks.

Risks and potential benefits may be perceived differently by different individuals and groups insociety. Researchers and REBs should take this into account in designing and reviewing research.They should also recognize that researchers and participants may not always see the risks andpotential benefits of a research project in the same way. In assessing risks and potential benefitsfor specific populations, researchers and REBs should understand the role of the culture, valuesand beliefs of the populations to be studied. In this regard REBs may consult ad hoc advisors asneeded. Researchers and REBs may also consult guidelines that exist for conducting research withthese populations (see Chapters 8, 9 and 10). Researchers shall demonstrate to their REBs thatthey have a reasonable understanding of the culture, values and beliefs of the population to bestudied, and the likely effects of their research upon them. This could be demonstrated, forexample, by referring to previous experience with conducting research with a similar population,or to published research on the effects of that type of research on the population being studied, orby presenting feedback from a community advisory group.

Article 2.9 The REB shall adopt a proportionate approach to research ethics review such that,as a preliminary step, the level of review is determined by the level of risk presentedby the research: the lower the level of risk, the lower the level of scrutiny (delegatedreview); the higher the level of risk, the higher the level of scrutiny (full boardreview). A proportionate approach to assessing the ethical acceptability of theresearch, at either level of review, involves consideration of the foreseeable risks,the potential benefits and the ethical implications of the research.

Application The proportionate approach to REB review encompasses both the initial assessmentof the level of risk to participants posed by a research project – used to determinethe level of review (i.e., delegated or full REB review [see Articles 6.11 to 6.17])– and the approach to the actual review of the research project itself. While allresearch shall be reviewed in light of the core principles of this Policy, the


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proportionate approach to REB review is intended to direct the most intensivescrutiny, time and resources, and correspondingly, the most protection, to the mostethically challenging research.

A proportionate approach to research ethics review starts with an assessment of themagnitude and probability of harms. Minimal risk research should normally receivedelegated review and above-minimal risk research shall receive full REB review.Whether the review is delegated, full-board, initial or continuing, foreseeable risksand potential benefits should be considered as well as the ethical implications ofthe research. The proportionate approach to REB review requires that a projecthave a favourable balance of risks and benefits in order to receive REB approval.The REB should make this assessment in light of the context of the research – thatis, elements of the research that may produce benefits or harms, or otherwise havean impact on the ethics of research. Regardless of the level of review selected, thereview should include the necessary expertise.

Both risks and potential benefits may span the spectrum from minimal tosubstantial. The concept of minimal risk (described above) provides a foundationfor the proportionate approach to REB review. The various applications of theproportionate approach to REB review are addressed in Article 6.12.

Risks to Researchers

Risks in research are not limited to participants. In their conduct of research, researchersthemselves may be exposed to risks that may take many forms (e.g., injury, incarceration). Risksto researchers may become a safety concern, especially for student researchers who are at alearning stage regarding the conduct of research, and who may be subject to pressures fromsupervisors to conduct research in unsafe situations.

While it is not a formal part of its responsibilities, an REB may raise concerns about the safety ofstudent researchers as part of its communication to the student researchers, and to their supervisors.Based on the level of risk, the REB may consider referring these concerns for review by anappropriate body within the institution.

Endnotes

1 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted HumanReproduction Act (2004, c. 2) and Guidelines for Human Pluripotent Stem Cell Research.

2 See guidance 3.2.1 of the International Conference on Harmonisation (ICH), Guidance for Industry –Good Clinical Practice: Consolidated Guideline, ICH Topic E6: Technical Requirements for theRegistration of Pharmaceuticals for Human Use (1996, adopted by Health Canada in 1997).



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Chapter 3THE CONSENT PROCESS

Introduction

This chapter sets out the ethical requirements for consent in research involving humans.Throughout this Policy, the term “consent” means “free, informed and ongoing consent.” For thepurpose of this Policy, “free” and “voluntary” are used interchangeably.

Respect for Persons implies that individuals who participate in research should do so voluntarily,understanding the purpose of the research, and its risks and potential benefits, as fully as reasonablypossible. Where a person has the capacity to understand this information, and the ability to act onit voluntarily, the decision to participate is generally seen as an expression of autonomy. The Policyrefers to the process of seeking consent from prospective participants, which may result in eitheragreement or refusal to participate. This process is meant to emphasize Respect for Persons. Underno circumstances may researchers proceed to conduct research with anyone who has refused toparticipate. Subject to exceptions set out in this Policy, consent must be obtained from participantsprior to the conduct of research.

Equally, Respect for Persons implies that those who lack the capacity to decide for themselvesshould nevertheless have the opportunity to participate in research that may be of benefit tothemselves or others. Authorized third parties acting on behalf of these individuals may decidewhether participation would be appropriate. For the purposes of this Policy, the term “authorizedthird party” (also known as “authorized third party decision makers”) refers to any person withthe necessary legal authority to make decisions on behalf of an individual who lacks the capacityto decide whether or not to participate or to continue to participate in a particular research project.These decisions involve considerations of Concern for Welfare and Justice.

Certain types of research require alternate processes for seeking consent. These are also describedin this chapter. Researchers may request an alteration to consent requirements if they can meetthe criteria of Article 3.7A. These include a requirement to satisfy the REB that it is impossible,impracticable or inappropriate (see Glossary) to address the research question without the requestedalteration. Where elements of the consent process may need to be adapted to the requirements ofa particular research project, the research ethics board (REB) can play an educational andconsultative role in determining the appropriate process for seeking and maintaining consent.REBs must consider whether the requested alterations are justified or whether another approachwould make it possible, practicable and appropriate to follow the normal consent requirements.

The head of the research team, also known as the principal investigator, is responsible for ensuringthat the consent process is followed. This person is also responsible for the actions of any memberof the research team involved in the consent process.

In addition to this Policy, researchers are responsible for ensuring that all applicable legal andregulatory requirements with respect to consent are met. In some circumstances, researchers may


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Chapter 3 – The Consent Process

have further legal obligations that may be determined in part by the nature of the research and thejurisdiction in which the research is being conducted.1

A. General Principles

Consent Shall Be Given Voluntarily

Article 3.1 (a) Consent shall be given voluntarily.

(b) Consent can be withdrawn at any time.

(c) If a participant withdraws consent, the participant can also request the with-drawal of their data or human biological materials.

Application (a) The voluntariness of consent is important because it respects human dignityand means that individuals have chosen to participate in research according totheir own values, preferences and wishes.

The approach to recruitment is an important element in assuring voluntariness.In particular, how, when and where participants are approached, and who re-cruits them are important elements in assuring (or undermining) voluntariness.In considering the voluntariness of consent, REBs and researchers should becognizant of situations where undue influence, coercion or the offer of incen-tives may undermine the voluntariness of a participant’s consent to participatein research.

Undue Influence

Undue influence and manipulation may arise when prospective participants arerecruited by individuals in a position of authority. The influence of power re-lationships (e.g., employers and employees, teachers and students, commandingofficers and members of the military or correctional officers and prisoners) onthe voluntariness of consent should be judged from the perspective of prospec-tive participants, since the individuals being recruited may feel constrained tofollow the wishes of those who have some form of control over them. This con-trol may be physical, psychological, financial or professional, for example, andmay involve offering some form of inducement or threatening some form ofdeprivation. In such situations, the control exerted in a power relationship mayplace undue pressure on the prospective participants. At the extreme, there canbe no voluntariness if consent is secured by the order of authorities.

REBs and researchers should also pay particular attention to elements of trustand dependency in relationships (e.g., between physician and patient or betweenprofessor and student). These relationships can impose undue influence on theindividual in the position of dependence to participate in research projects. Anyrelationship of dependency, even a nurturing one, may give rise to undue


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influence even if it is not applied overtly. There may be a greater risk of undueinfluence in situations of ongoing or significant dependency.

Pre-existing entitlements to care, education and other services should not beprejudiced by the decision of whether or not to participate in, or to withdrawfrom, a research project. Accordingly, for example, a physician should ensurethat continued clinical care is not linked to research participation. Similarly,where students do not wish to participate in research studies for course credits,they should be offered a comparable alternative.

Coercion

Coercion is a more extreme form of undue influence, involving a threat ofharm or punishment for failure to participate. Coercion would negate thevoluntariness of a decision to participate, or to remain, in a research project.

Incentives

Incentives are anything offered to participants, monetary or otherwise, for par-ticipation in research (incentives differ from reimbursements and compensationfor injury, which are discussed in Article 3.2[j]). Because incentives are usedto encourage participation in a research project, they are an important consid-eration in assessing voluntariness. Where incentives are offered to participants,they should not be so large or attractive as to encourage reckless disregard ofrisks. This is a particular consideration in the case of healthy volunteers for theearly phases of clinical trials, as discussed in Article 11.1. The offer of incen-tives in some contexts may be perceived by prospective participants as a wayfor them to gain favour or improve their situation. This may amount to undueinducement and thus negate the voluntariness of participants’ consent.

This Policy neither recommends nor discourages the use of incentives. Theonus is on the researcher to justify to the REB the use of a particular model andthe level of incentives. In considering the possibility of undue influence in re-search involving financial or other incentives, researchers and REBs should besensitive to issues such as the economic circumstances of those in the pool ofprospective participants, the age and decision-making capacity of participants,the customs and practices of the community, and the magnitude and probabilityof harms (see Chapter 4, Section B). Guardians and authorized third partiesshould not receive incentives for arranging the involvement in research of theindividual they represent. However, they may accept reasonable incentives orcompensation on behalf of that individual, as long as these are suitable to thecircumstances.

(b) To maintain the element of voluntariness, participants shall be free to withdrawtheir consent to participate in the research at any time, and need not offer anyreason for doing so. In some cases, however, the physical practicalities of the


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project may prevent the actual withdrawal of the participant partway through,for example, if the project involves only a single intervention, or if thetermination of a medical research procedure may compromise the safety of theparticipant.

The participant should not suffer any disadvantage or reprisal for withdrawingnor should any payment due prior to the point of withdrawal be withheld. Ifthe research project used a lump-sum incentive for participation, the participantis entitled to the entire amount. If a payment schedule is used, participants shallbe paid in proportion to their participation.

(c) The consent process should set out any circumstances that do not allowwithdrawal of data or human biological materials once collected. In someresearch projects, the withdrawal of data or human biological materials maynot be possible (e.g., when personal information has been anonymized andadded to a data pool). Researchers must provide a rationale to the REB for usingcollection methods that do not permit subsequent withdrawal of data or humanbiological materials. Where the terms of the research do not allow forwithdrawal of their data or human biological materials, the identity of theparticipants shall be protected at all times during the project and after itscompletion. Participants shall also be informed that it is impracticable, if notimpossible, to withdraw results once they have been published or otherwisedisseminated.

Consent Shall Be Informed

Article 3.2 Researchers shall provide to prospective participants, or authorized third parties,full disclosure of all information necessary for making an informed decision toparticipate in a research project.

Application At the commencement of any process of consent, researchers (or their qualifiedrepresentatives) shall provide prospective participants with the information set outin the following list, as appropriate to the particular research project. Not all thelisted elements are required for all research. However, additional information maybe required in particular types of research or under particular circumstances.

If a researcher does not include some of the listed disclosure requirements, theyshould explain to the REB why these requirements do not apply to that particularproject. It is also up to the REB to consider whether all elements listed, or additionalelements, are necessary to the consent process of the research project.

The information generally required for informed consent includes:

(a) information that the individual is being invited to participate in a researchproject;


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(b) a statement of the research purpose in plain language, the identity of theresearcher, the identity of the funder or sponsor, the expected duration andnature of participation, a description of research procedures, and an explanationof the responsibilities of the participant;

(c) a plain language description of all reasonably foreseeable risks and potentialbenefits, both to the participants and in general, that may arise from researchparticipation;

(d) an assurance that prospective participants:

• are under no obligation to participate; are free to withdraw at any timewithout prejudice to pre-existing entitlements;

• will be given, in a timely manner throughout the course of the researchproject, information that is relevant to their decision to continue or withdrawfrom participation; and

• will be given information on the participant’s right to request the withdrawalof data or human biological materials, including any limitations on thefeasibility of that withdrawal;

(e) information concerning the possibility of commercialization of researchfindings, and the presence of any real, potential or perceived conflicts of intereston the part of the researchers, their institutions or the research sponsors;

(f) the measures to be undertaken for dissemination of research results and whetherparticipants will be identified directly or indirectly;

(g) the identity and contact information of a qualified designated representativewho can explain scientific or scholarly aspects of the research to participants;

(h) the identity and contact information of the appropriate individual(s) outside theresearch team whom participants may contact regarding possible ethical issuesin the research;

(i) an indication of what information will be collected about participants and forwhat purposes; an indication of who will have access to information collectedabout the identity of participants, a description of how confidentiality will beprotected (see Article 5.2), a description of the anticipated uses of data; and in-formation indicating who may have a duty to disclose information collected,and to whom such disclosures could be made;

(j) information about any payments, including incentives for participants,reimbursement for participation-related expenses and compensation for injury;

(k) a statement to the effect that, by consenting, participants have not waived anyrights to legal recourse in the event of research-related harm; and


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(l) in clinical trials, information on stopping rules and when researchers mayremove participants from trial.

For consent to be informed, prospective participants shall be given adequate time and opportunityto assimilate the information provided, pose any questions they may have, and discuss and considerwhether they will participate. The time required for this initial phase of the consent process willdepend on such factors as the magnitude and probability of harms, the complexity of theinformation conveyed, and the setting where the information is given.

The key to informed consent is that prospective participants understand the information beingconveyed to them by researchers. Researchers and REBs should consider how best to convey thatinformation to facilitate understanding. For example, written documentation may be supplementedwith audio and/or visual aids, or accompanied by video presentations.

When language barriers necessitate the assistance of an intermediary for communication betweenthe research team and participants, the researcher should select an intermediary who has the nec-essary language skills to ensure effective communication (see Article 4.1). The involvement ofsuch intermediaries may raise confidentiality issues (see Article 5.2).

Paragraphs (a) to (c) require researchers to clearly explain the nature and goals of the research,and other essential information, in a manner that best promotes understanding on the part ofprospective participants.

Paragraph (b) requires the disclosure of those who support a particular research project, throughfunding or sponsorship. It is unethical for researchers to engage in clandestine activities forintelligence, police or military purposes under the guise of research.

Paragraph (c) requires researchers to consider all reasonably foreseeable risks that may result fromparticipation. When research is conducted about an organization or a community, researchersshould inform prospective participants within that organization or community of the extent towhich the organization or community is collaborating with the research, as well as any risk thiscollaboration may pose to the participant.

Paragraph (d) helps to ensure the effectiveness of Article 3.1 – that a prospective participant’schoice to participate is voluntary. Paragraph (d) also supports the requirement that the consentprocess continue throughout the research. The consent process should set out any circumstancesthat do not allow withdrawal of data or human biological materials once collected (see Article3.1(c)).

Paragraph (e) aims at managing real, potential or perceived conflicts of interests. Researchersshould separate, to the greatest extent possible, their role as researcher from their other roles astherapists, caregivers, teachers, advisors, consultants, supervisors, employers or the like. If aresearcher is acting in dual roles, this fact must always be disclosed to the participant. Conflict ofinterest matters are further elaborated in Chapter 7.


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Paragraph (f) requires that researchers provide a reasonable explanation of the measures they willundertake to publish and otherwise disseminate the results of the research – to the extent that it isfeasible, and in a manner that is appropriate. Beyond the ethical obligation to disseminate resultsin such areas as clinical trials, this requirement is grounded on the reasonable expectation of par-ticipants that results will be published or otherwise disseminated in the public domain to advancesocietal knowledge (addressed further in Articles 11.3 and 11.12). With respect to research involvingAboriginal peoples and disclosure of information, see Chapter 9.

Paragraph (h) acknowledges that some institutions may decide either to name an ombudsman forparticipants, or designate a resource person to handle queries, receive complaints, and transmitthose complaints to the REB. This is a matter for institutions to determine.

Paragraph (i) touches on issues of privacy and confidentiality, secondary use of data, and thepossibility of compelled disclosure by the researcher to third parties for administrative and/or legalpurposes. These issues are addressed in further detail in Chapter 5 and, in particular, Article 5.2.

Paragraph (j) ensures that participants are informed of the payments they will receive (if any) fortheir participation. Reimbursement for participation-related expenses is intended to ensure thatparticipants are not put at a direct or indirect financial disadvantage for the time and inconvenienceof participation in research. Direct expenses are costs incurred because of research participation(e.g., paying for transportation to, or parking at, the research site) while indirect expenses refer tolosses that arise from participation (e.g., taking unpaid leave from work). Participants should alsobe informed about any compensation they may be entitled to for research-related injuries.

Paragraph (l) is intended to inform the prospective participant in clinical trials of circumstancesunder which the researcher may end the participant’s involvement in a research project. Clinicaltrials have stopping rules: statistically significant end points and safety considerations determinedin advance, which, once reached, dictate that the trial must be terminated. As well, researchersmay remove participants who are not following the procedures of the clinical trial or for safetyreasons (see Article 11.7).

Consent Shall Be an Ongoing Process

Article 3.3 Consent shall be maintained throughout the research project. Researchers have anongoing duty to provide participants with all information relevant to their ongoingconsent to participate in the research.

Application Consent encompasses a process that begins with the initial contact (e.g.,recruitment) and carries through to the end of participants’ involvement in theproject. Throughout the process, researchers have an ongoing duty to provideparticipants and REBs with all information relevant to participants’ ongoing consentto participate in the research. The researcher has an ongoing ethical and legalobligation to bring to participants’ attention any changes to the research projectthat may affect them. These changes may have ethical implications, or may be


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germane to their decision to continue research participation, or may be relevant tothe particular circumstances of individual participants. In particular, researchersshall disclose changes to the risks or potential benefits of the research. This givesparticipants the opportunity to reconsider the basis for their consent in light of thenew information.

Rather than an age-based approach to consent, TCPS 2 advocates an approachbased on decision-making capacity as long as it does not conflict with any lawsgoverning research participation. Some children begin participation in a project onthe basis of consent from an authorized third party (due to the determination thatthey lacked capacity to decide on their own behalf) and on the basis of their ownassent (see Article 3.10). In these cases, if the children mature sufficiently to decideon their own behalf (subject to legal requirements), the researcher must seek thechildren's autonomous consent in order for their participation to continue. Similarly,in the case of children who are unable to assent to research participation (e.g., infants)at the beginning of a project, the researcher must seek their assent to continue theirparticipation once they are able to understand the purpose of the research as well asits risks and benefits.

Incidental Findings

“Incidental findings” is a term that describes unanticipated discoveries made in the course of re-search but that are outside the scope of the research. Incidental findings are considered to bematerial incidental findings if they have been interpreted as having significant welfare implicationsfor the participant. Material incidental findings may appear at any stage of the research. This mayinclude, for example, while screening for eligibility for inclusion in a study or while collectingbaseline information, both of which may involve the prospective participants’ consent.

If researchers are unsure of how to interpret findings or are uncertain whether findings are material,they should consult with their colleagues and/or refer to standards in the discipline. Researchersshould exercise caution in disclosing incidental findings that may cause needless concern to par-ticipants such as participant anxiety, unnecessary costs and burdens of follow-up; or may affecteligibility for employment or insurance.

Article 3.4 Researchers have an obligation to disclose to the participant any material incidentalfindings discovered in the course of research.

Application In some areas of research, such as medical and genetic research, there is a greaterlikelihood of material incidental findings. When material incidental findings arelikely, researchers should develop a plan indicating how they will disclose suchfindings to participants, and submit this plan to the REB. If there is uncertainty asto whether a research project warrants such a plan, researchers and REBs can makethis determination on a case-by-case basis.

When necessary, researchers should direct participants to a qualified professionalto discuss the possible implications of the incidental findings for their welfare. In


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some cases, incidental findings may trigger legal reporting obligations andresearchers should be aware of these obligations (see Article 5.1).

A researcher may request an exception to the obligation to disclose materialincidental findings, based on the impracticability or impossibility of disclosing suchfindings to the participant. “Impracticable” refers to undue hardship or onerousnessthat jeopardizes the conduct of the research; it does not mean mere inconvenience.Disclosure may be impossible or impracticable (see Glossary) when the group isvery large or its members are likely to be deceased, geographically dispersed ordifficult to track. The onus is on the researcher to justify to the REB the need forthe exception. REBs should decide whether exceptions apply on a case-by-casebasis.

Consent Shall Precede Collection of, or Access to, Research Data

Article 3.5 Research shall begin only after the participants, or their authorized third parties,have provided their consent.

Application In keeping with the principle of Respect for Persons, participants shall provide theirconsent prior to engaging in research. This is the clearest demonstration that theirparticipation is based on consideration of the risks and potential benefits of theresearch project, and other principles in this Policy.

There are exceptions to this general ethical requirement, however, set out in Articles3.7A and 3.8.

This article does not apply to conversations that researchers may have withprospective participants as part of the development of the design of their research.These preliminary conversations – which may include negotiations concerning theterms on which a researcher may engage with a particular community or group –do not in themselves constitute research, and therefore do not require consent (seeChapter 2, Article 6.11, Articles 9.3 to 9.6, and Article 10.1).

Critical Inquiry

Article 3.6 In critical inquiry, permission is not required from an institution, organization orother group in order to conduct research on them. If a researcher engages theparticipation of members of any such group without the group’s permission, theresearcher shall inform participants of any foreseeable risk that may be posed bytheir participation.

Application Research in the form of critical inquiry, that is, the analysis of social structures oractivities, public policies, or other social phenomena, requires an adjustment in theassessment of consent. Where the goal of the research is to adopt a critical perspec-


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tive with respect to an institution, organization or other group, the fact that the in-stitution, organization or group under study may not endorse the research projectshould not be a bar to the research receiving ethics approval. Where social sciencesor humanities researchers seek knowledge that critiques or challenges the policiesand practices of institutions, governments, interest groups or corporations, re-searchers do not need to seek the organization’s permission to proceed with theproposed research. If institutional approval were required, it is unlikely that researchcould be conducted effectively on such matters as institutional sexual abuse or agovernment’s silencing of dissident scientists. Important knowledge and insightsfrom research would be forgone. Specific requirements pertain to Aboriginal or-ganizations, which are discussed in detail in Articles 9.4 to 9.8.

Researchers and REBs should be aware that institutions, organizations or othergroups under study may have requirements for allowing access to their sites and toparticipants, and that some of these may have established mechanisms or guidelinese.g., school boards, Aboriginal communities (see Chapter 9), correctional services,and community groups. Refer to Article 8.3 for more information. Nevertheless,REBs should not prohibit research simply because the research is unpopular orlooked upon with disfavour by a community or organization, in Canada or abroad.Similarly, REBs should not veto research on the grounds that the government inplace or its agents have not given approval for the research project, or have ex-pressed a dislike for the researchers.

However, individuals who are approached to participate in a research project abouttheir organization should be fully informed about the views of the organizationregarding the research, if these are known. Researchers shall inform participantswhen the permission of the organization has not been obtained. Researchersengaging in critical inquiry need to be attentive to risks, both of stigmatization orbreach of privacy, to those who participate in research about their organization. Inparticular, prospective participants should be fully informed of the possibleconsequences of participation.

REBs should, however, legitimately concern themselves with the welfare of participantsand the security of research materials in such circumstances. When participants arevulnerable to risks from third parties (e.g., authoritarian regimes, gang leaders,employers) on account of their involvement in research, researchers should ensure thatcopies of field materials are kept in secure locations. When sharing research materialssuch as consent forms or transcripts of field notes with participants, researchers musthonour their commitment to protect the anonymity and confidentiality of participantsto ensure that their human rights, and the ethical principles set out in this Policy, arenot compromised. In general, regardless of where the researchers conduct their research,researchers and REBs should concern themselves with safeguarding information whileit is in transit (see Articles 5.1 to 5.4).


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REBs should also be aware that some research, involving critical assessments ofpublic, political or corporate institutions and associated public figures, for example,may be legitimately critical and/or opposed to the welfare of those individuals in aposition of power, and may cause them some harm. There may be a compellingpublic interest in this research. Therefore, it should not be blocked through the useof risk-benefit analysis. Such research should be carried out according to theprofessional standards of the relevant discipline(s) or field(s) of research. Wherean individual in a position of power is invited to be interviewed or gives access toprivate papers and thus becomes a participant as defined by this Policy, Article 3.2applies (see also Article 3.12, Article 9.7 and Article 10.2). In such cases, thebalance of risks to those who are the object of the research is mainly consideredalong with the potential benefit of new knowledge to society and the indirectbenefits to the population affected by the public, political or corporate institutionsto which the participant belongs.

B. Departures from General Principles of Consent

Articles 3.1 to 3.5 set out the default requirements for seeking the consent of individuals toparticipate in research. However, there are some research questions that cannot be answeredwithout an alteration to these consent requirements. For example, the question of what factorsinfluence whether people will choose to return a wallet dropped by someone on the street couldnot be answered if the prospective participants were alerted to the presence of the researcherobserving them and to the presence of the confederate dropping the wallet in front of them.Alterations to consent requirements may include providing prospective participants with onlypartial disclosure about the purpose of the study, deceiving prospective participants entirely aboutthe purpose of the study, and not informing participants that they (or their data or biologicalmaterials) are involved in a study.

Article 3.7A sets out the conditions which a researcher must satisfy in order for an REB to approveresearch involving any alteration to consent requirements. The lack of prior consent, or of fullyinformed consent, may be addressed through debriefing conducted as soon as possible followingparticipants’ involvement in the research, and within a timeframe that allows participants towithdraw their data or human biological materials (where possible, practicable and appropriate[see Glossary]). Article 3.7B provides guidance with respect to debriefing in the context of analteration to consent requirements.

Alterations to Consent Requirements

Article 3.7A The REB may approve research that involves an alteration to the requirements forconsent set out in Articles 3.1 to 3.5 if the REB is satisfied, and documents, that allof the following apply:

(a) the research involves no more than minimal risk to the participants;


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(b) the alteration to consent requirements is unlikely to adversely affect the wel-fare of participants;

(c) it is impossible or impracticable (see Glossary) to carry out the research andto address the research question properly, given the research design, if theprior consent of participants is required;

(d) in the case of a proposed alteration, the precise nature and extent of any pro-posed alteration is defined; and

(e) the plan to provide a debriefing (if any) which may also offer participants thepossibility of refusing consent and/or withdrawing data and/or human bio-logical materials, shall be in accordance with Article 3.7B.

Application In the circumstances described under Article 3.7A, the nature of the research mayjustify some alteration(s) to consent requirements if the potential benefits outweighthe foreseeable risks. As stated in paragraphs (a) and (b), the risks to participantsmust fall within the definition of no more than minimal risk (Chapter 2, Section B)and the alteration to the requirements must be unlikely to adversely affect partici-pants’ welfare. The potential benefits to be considered include benefits to theparticipants themselves, to the group they represent and/or to society more gener-ally. Note that in paragraph (c) “impracticable” refers to undue hardship oronerousness that jeopardizes the conduct of the research. It does not refer to mereinconvenience. Researchers must clearly describe the nature and extent of the pro-posed alteration(s) (paragraph (d)) and their plans with respect to debriefingparticipants, in accordance with Article 3.7B (paragraph (e)). It is the responsibilityof researchers to justify the need for any alteration to consent requirements to thesatisfaction of their REB(s).

Alterations to consent should be permitted only to the extent necessary. If the aimsof the research can be achieved with a design that allows for full – or fuller – priordisclosure (in accordance with Articles 3.1 to 3.5), then that design must be adopted.It is the responsibility of REBs, however, to understand that certain research meth-ods necessitate a different approach to consent, and to exercise judgment onwhether the need for the research justifies any alterations to consent requirements.In determining whether to allow any alterations to consent requirements, REBsmust consider both the proposed alterations and the proposed plan for debriefingor justification for not debriefing. In other words, the guidance in Articles 3.7A and3.7B must be considered together in determining whether an alteration to consentrequirements is ethically acceptable.

It should be noted that in some cases of randomization and blinding in clinicaltrials, neither the participants nor the researchers know which treatment the partic-ipant will be receiving. As long as participants are informed of the probability oftheir assignment to each arm of the trial, this random and blind assignment doesnot constitute an alteration to consent requirements.


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Research Involving Partial Disclosure or Deception

Some social science research, particularly in psychology, seeks to learn abouthuman responses to situations that have been created experimentally. Some typesof research can be carried out only if the participants do not know the true purposeof the research in advance. For example, some social science research that criticallyprobes the inner workings of publicly accountable institutions might never beconducted without the limited use of partial disclosure. In some research that usespartial disclosure or deception, participants may be asked to perform a task andinformed about only one of several elements the researchers are observing.Research employing deception can involve a number of techniques, such as givingparticipants false information about themselves, events, social conditions and/orthe purpose of the research. For such techniques to fall within the exception to thegeneral requirement of full disclosure for consent, the research must meet all ofthe requirements of Article 3.7A.

Exception to the Requirement to Seek Prior Consent

In the circumstances described under Article 3.7A, an REB may allow an exceptionto the requirement that researchers seek consent from participants prior to collectionof data and/or human biological materials. Researchers must demonstrate that thisalteration to consent requirements is necessary to address the research question andthat the lack of prior consent will not have an adverse impact on the welfare ofparticipants. They must also demonstrate that the benefits of the research, whetherdirect, indirect or societal, justify any risks associated with no prior consent. Forexample, a study of the effect of environmental toxins on the members of nearbycommunities may involve the analysis of the level of toxins present in discardedhair clippings from the barber shops of these communities. The researchers maymake the case that the collection and analysis of the hair clippings pose no risks toparticipants, that seeking prior consent for the use of the hair clippings could leadto a general panic about environmental toxins among the members of thesecommunities, and that the possible benefits of identifying environmental toxins sothat they can be removed, justify this approach to the research question.

REBs must consider whether it is in the participants’ best interests to be informedof the research (and to what extent) if not before, then afterwards (see Article 3.7B).If the research design calls for no prior consent and no debriefing, then theparticipants may never know of their involvement. This raises ethical issues thatdiffer somewhat from other alterations to consent requirements as these participantswill have no opportunity to ask questions about the nature and purpose of the studyor to request the withdrawal of their data and/or human biological materials (wherepossible, practicable and appropriate [see Glossary]). In light of these issues, theREB should apply greater scrutiny (see Article 2.9) to the justification for anexception to the requirement to seek prior consent and an exception to therequirement to debrief (see Article 3.7B).


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Note that Article 3.7A does not address the exception to the requirement to seekconsent for secondary use of identifiable information; this topic is addressed inArticle 5.5A.

Participants in Vulnerable Circumstances

In considering the need for an alteration to consent requirements, researchers andREBs should also consider whether the prospective participants (as individuals,groups, or populations) are in vulnerable circumstances (see Article 4.7). Theexistence of vulnerable circumstances may require greater effort to minimize risksto participants and/or maximize potential benefits (see Chapter 2, Section B).

Population and Public Health Research

Due to the nature of the research question and the need to test interventions thatoperate at the population level, some population and public health studies cannotbe done with prior informed consent. For example, a cluster-randomized trialcomparing the efficacy of two different stop smoking campaigns in two or morecommunities would not be able to answer the research question if communitymembers were alerted, through a consent process, to the presence of the campaignand the existence of other campaigns in different communities as this knowledgecould affect the group response to the campaigns. Similarly, in a study comparingthe effectiveness of different types of water treatment facilities, it would not bepossible to obtain individual informed consent for the type of water treatment eachindividual in a community is to receive. Researchers should, however, seekcommunity engagement prior to data collection (see Chapter 9).

It is up to researchers to adequately explain why their research question cannot beanswered without an exception to the requirement to seek prior consent. REBs areadvised to have population and public health expertise involved in reviews of thistype of research (see Articles 6.4 and 6.5).

Debriefing in the Context of Alterations to Consent Requirements

Article 3.7B (a) Debriefing must be a part of all research involving an alteration to consentrequirements (see Article 3.7A) whenever it is possible, practicable andappropriate.

(b) Participants in such research must have the opportunity to refuse consent andrequest the withdrawal of their data and/or human biological materialswhenever possible, practicable and appropriate (see Article 3.1)

Application Debriefing

Where alterations to consent have been used, debriefing is an important mechanismin maintaining the participant’s trust in the research community. Often, debriefingin this context can be a simple and straightforward candid disclosure as described


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in Article 3.2. To allow for the possibility that participants may wish to withdrawtheir data or biological materials once they know the details of the study (see Post-debriefing option to withdraw data and/or human biological materials in thisapplication), debriefing should take place while it is still possible to giveparticipants this option (e.g., prior to merging or de-identification).

Researchers must explain why participants were temporarily led to believe that theresearch, or some aspect of it, had a different purpose, or why participants receivedless than full disclosure. In cases where participants were not asked for their consentprior to collection of data and/or human biological materials, researchers mustexplain why this exception to consent requirements was necessary. Researchersmust give details about the importance of the research, the necessity of having touse alterations to consent requirements, and address any concerns raised byparticipants. In order to address any misconceptions that may have arisen,researchers must explain why these research procedures were necessary to obtainscientifically valid findings. When debriefing, researchers should be alert andsensitive to participants’ needs, feelings, reactions and concerns. REBs shouldassess the risks and benefits of the debriefing itself and whether the proposed planis appropriate for participants – particularly those who are in vulnerablecircumstances and/or who lack the capacity to make a consent decision.

When it is not appropriate to provide complete details of the research in adebriefing, the level of detail should be determined by considering the impact ofthe information on the participant in terms of foreseeable risks and potentialbenefits. It should also be proportionate to the sensitivity of the issue and tailoredto the decision-making capacity of participants. For example, in research involvingchildren who do not have the capacity to make a consent decision on their ownbehalf it may be more appropriate to debrief the parents, guardians or authorizedthird parties as well as the participants themselves. The debriefing process shouldbe based upon the participants’ capacity to understand the information provided.Note that in some cases, excluding children from a debriefing may be justified (e.g.,when debriefing is focused on findings of a sensitive nature that relate to the child,such as intellectual capacity). In other cases, it may be more appropriate to debriefthe entire family or community. Immediate, full debriefing of all individuals whohave contributed data may not be possible or practicable in all cases. In studieswith data collection over a longer term, debriefing may have to be deferred untilthe end of the project.

Post-debriefing option to withdraw data and/or human biological materials

At the time of debriefing, participants should, whenever possible, practicable andappropriate, be able to indicate their consent/assent or their refusal for the continueduse of their data or human biological materials. In cases where participants expressconcerns about their participation in a project, the researcher must address theirconcerns (e.g., by explaining the rationale for the research design, answering


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questions about data usage or privacy). Regardless of whether any concerns areraised, the researcher must give participants the option of removing their data and/orhuman biological materials unless this option is impossible, impracticable orinappropriate (see Glossary).

In determining whether it is ethically acceptable not to permit the withdrawal ofdata and/or human biological materials, REBs must consider whether withdrawalof data is possible or practicable. If researchers intend to collect data or humanbiological materials without identifying information, or if all identifyinginformation will be removed, it may not be possible for researchers to withdrawthe data associated with specific individuals. Researchers must provide a rationalefor using collection methods that do not permit subsequent withdrawal of data orhuman biological materials. REBs must also consider whether the option towithdraw data is appropriate. In some types of research, permitting the withdrawalof data and/or human biological materials could skew the results of the research,invalidating the study and denying potential benefits to society. The invalidationof study findings may also demonstrate a lack of respect of the contributions madeby other participants. The onus is on researchers, however, to satisfy the REB thatthe withdrawal of data or biological materials by individual participants wouldthreaten the validity of their research.

Where the terms of the research proposal do not permit the participants to withdrawtheir data, in the absence of the consent of the participant, the identity of theparticipants shall be protected at all times during and following completion of theproject. Participants who express concern about the conduct of the project at thetime of debriefing, or who contest the limits imposed on withdrawing their data,should be given the contact information for the REB that approved the research.Researchers must report to the REB concerns about the conduct of the project raisedby participants at the time of debriefing.

Exception to the requirement to debrief

There may be circumstances in which debriefing is impossible, impracticable orinappropriate in research involving alterations to consent requirements. Note that“impracticable” refers to undue hardship or onerousness that jeopardizes theconduct of the research. It does not refer to mere inconvenience. The onus is onresearchers to satisfy the REB that their research involves circumstances that makeit impossible, impracticable or inappropriate to offer a debriefing.

When considering whether to grant an exception to the requirement to debrief,REBs should consider the level of potential harm to the participant which thedebriefing itself may cause and the impact of the debriefing on the feasibility ofthe research. When seeking an exception to the requirement to debrief, researchersmust also provide a plan to disseminate information about the study to participantsand/or their communities (e.g., through local media, direct mail). This plan is ofparticular importance when the findings may affect participant welfare.


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Consent for Research in Individual Medical Emergencies

This section addresses the exception to consent in situations where an individual who requiresurgent medical care is unable to provide consent for research due to loss of consciousness ordecision-making capacity – and the delay to seek authorized third party consent could seriouslycompromise that individual’s health. Certain types of medical emergency practices can beevaluated only when they occur, hence the need for this exception.

This section is to be distinguished, however, from situations where there is a publicly declaredemergency (such as the SARS crisis or a major flood) that disrupts the ordinary system forobtaining REB approval for research. For guidance on research ethics review during a publiclydeclared emergency, see Articles 6.21 and 6.22.

Article 3.8 Subject to all applicable legal and regulatory requirements, research involvingmedical emergencies shall be conducted only if it addresses the emergency needsof the individuals involved, and then only in accordance with criteria establishedin advance of such research by the REB. The REB may allow research that involvesmedical emergencies to be carried out without the consent of participants, or oftheir authorized third party, if all of the following apply:

(a) a serious threat to the prospective participant requires immediate intervention;

(b) either no standard efficacious care exists or the research offers a realisticpossibility of direct benefit to the participant in comparison with standard care;

(c) either the risk is not greater than that involved in standard efficacious care, orit is clearly justified by the prospect for direct benefits to the participant;

(d) the prospective participant is unconscious or lacks capacity to understand therisks, methods and purposes of the research project;

(e) third party authorization cannot be secured in sufficient time, despite diligentand documented efforts to do so; and

(f) no relevant prior directive by the participant is known to exist.When a previously incapacitated participant regains decision-making capacity, orwhen an authorized third party is found, consent shall be sought promptly forcontinuation in the project, and for subsequent examinations or tests related to theresearch project.

Application For purposes of studying potential improvement in the treatment of life-threateningconditions, Article 3.8 outlines an exception (in addition to that in Article 3.7A) tothe general obligation of seeking consent from those participating in research.

It is the responsibility of researchers to justify to the REB the need for thisexception. The underlying assumption of Article 3.8 is that participants could notreceive any direct benefits of the research without setting aside the need for the


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researcher to seek the prior consent of participants, or of their authorized third party.Article 3.8 indicates that research in emergency medicine must be reviewed by theREB, be restricted to the emergency needs of the participants, and be conductedunder criteria designated by the REB.

It is unethical to expose participants to any additional risk without their consent ifstandard efficacious care exists, unless it can clearly be shown that there is arealistic possibility of meaningful improvement of the participant’s condition.Accordingly, paragraphs (b) and (c) of Article 3.8 indicate that researchers andREBs must assess the risks and potential benefits of proposed research againstexisting standard efficacious care.

To respect the autonomy of the participant, Article 3.8(e) requires researchers toundertake diligent efforts to contact authorized third parties, if practicable, and todocument such efforts for the benefit of both the participant and the continuingethics review functions of the REB. The article also requires that participants whoregain decision-making capacity be promptly afforded the opportunity to consentto their continued participation. Concern for the patient’s welfare is paramount andshould be informed by ethical and professional judgment.

Because their incapacity to make decisions puts them in vulnerable circumstances,prospective participants for emergency research are owed special ethical obligationsand protection commensurate with the risks involved. Their welfare should beprotected by additional safeguards, where feasible and appropriate. These mightinclude: additional scientific, medical or REB consultation; procedures to identifyprospective participants in advance so that consent may be sought prior to theoccurrence of the emergency situation; consultation with former and prospectiveparticipants; and special monitoring procedures to be followed by data safety andmonitoring boards.

C. Decision-Making Capacity

Decision-making capacity refers to the ability of prospective or actual participants to understandrelevant information presented about a research project, and to appreciate the potentialconsequences of their decision to participate or not participate. This ability may vary according tothe complexity of the choice being made, the circumstances surrounding the decision, or the pointin time at which consent is sought. The determination of capacity to decide whether or not toparticipate in research, then, is not a static determination. It is a process that may change overtime, depending on the nature of the decision the prospective participant needs to make, and onany changes in the participant’s condition. Assessing decision-making capacity is a question ofdetermining, at a particular point in time, whether a participant (or prospective participant)sufficiently understands the nature of a particular research project, and the risks, consequencesand potential benefits associated with it.

One may therefore have diminished capacity in some respects but still be able to decide whetherto participate in certain types of research. Researchers should be aware of all applicable legal and


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regulatory requirements with respect to decision-making capacity and/or consent. These may varyamong jurisdictions. Authorized third parties who are asked to make a consent decision on behalfof a prospective participant should also be aware of their legal responsibilities.

In keeping with the principle of Justice, those who lack the capacity to decide on their own behalfmust neither be unfairly excluded from the potential benefits of research participation, nor may theirlack of decision-making capacity be used to inappropriately include them in research. REBs andresearchers should be aware of these ethical considerations and seek to find a balance between themfor the benefit of prospective participants who lack decision-making capacity (see Chapter 4).

As indicated in Chapter 1, Respect for Persons and Concern for Welfare entails particular ethicalobligations to individuals in vulnerable circumstances. Such obligations often translate into specialprocedures to promote and protect their interests. This may include the development of consentmaterials that are appropriate to the cognitive and communication abilities of prospectiveparticipants. Articles 3.9, 3.10 and 3.11 describe special procedures for research involvingindividuals who lack decision-making capacity.

Article 3.9 For research involving individuals who lack the capacity, either permanently ortemporarily, to decide for themselves whether to participate, the REB shall ensurethat, as a minimum, the following conditions are met:

(a) the researcher involves participants who lack the capacity to decide on theirown behalf to the greatest extent possible in the decision-making process;

(b) the researcher seeks and maintains consent from authorized third parties inaccordance with the best interests of the persons concerned;

(c) the authorized third party is not the researcher or any other member of theresearch team;

(d) the researcher demonstrates that the research is being carried out for theparticipant’s direct benefit, or for the benefit of other persons in the samecategory. If the research does not have the potential for direct benefit to theparticipant but only for the benefit of the other persons in the same category,the researcher shall demonstrate that the research will expose the participant toonly a minimal risk and minimal burden, and demonstrate how the participant’swelfare will be protected throughout the participation in research; and

(e) when authorization for participation was granted by an authorized third party,and a participant acquires or regains decision-making capacity during the courseof the research, the researcher shall promptly seek the participant’s consent asa condition of continuing participation.

Application The decision of authorized third parties should be based on their knowledge of theprospective participants, and on consideration of the prospective participants’welfare. The third parties should not be in a position of conflict of interest whenmaking their decision.


Article 3.9 outlines other safeguards to protect those who lack the capacity to decidewhether or not to participate in research. The article details several considerationsrelevant to the use of third party authorization. Beyond the legal and regulatoryrequirements for seeking consent from authorized third parties, family members andfriends may also provide information to the authorized third party about the interestsand previous wishes of prospective participants. An authorized third party shouldtake into account any research directives given in accordance with Article 3.11.

Article 3.10 Where an authorized third party has consented on behalf of an individual who lackslegal capacity, but that person has some ability to understand the significance ofthe research, the researcher shall ascertain the wishes of that individual with respectto participation. Prospective participants’ dissent will preclude their participation.

Application Many individuals who lack legal capacity to make decisions may still be able toexpress their wishes in a meaningful way, even if such expression may not fulfilall of the requirements for consent. Prospective participants may be capable ofverbally or physically assenting to, or dissenting from, participation in research.Those who may be capable of assent or dissent include:

(a) those whose decision-making capacity is in the process of development, suchas children whose capacity for judgment and self-direction is maturing;

(b) those who once were capable of making an autonomous decision regardingconsent but whose decision-making capacity is diminishing or fluctuating; and

(c) those whose decision-making capacity remains only partially developed, suchas those living with permanent cognitive impairment

While their assent would not be sufficient to permit them to participate in theabsence of consent by an authorized third party, their expression of dissent or signssuggesting they do not wish to participate must be respected.

Research Directives

Although advance directives for treatment are recognized as a legitimate tool in health care, theuse of directives in the context of research is not well developed and they have no legal status.For the purposes of this Policy, research directives should be understood to express an individual’spreferences for participation in future research in the event that the individual loses capacity.Research directives are written instructions to be used by the authorized third party as informationabout a prospective participant’s preferences when the third party is asked to provide substituteconsent.

The efficacy of research directives is unknown and their legal status has not yet been recognizedor tested. Research directives, nevertheless, are congruent with this Policy’s core principle ofRespect for Persons. The use of research directives respects the right of individuals to expresstheir preference regarding participation in research and respects privacy by allowing individualsto control information about themselves and materials from their bodies. Authorized third parties

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45TCPS 2 (2014)

should consult with an individual’s research directive when deciding whether to consent toparticipation in research on behalf of that individual.

Article 3.11 Where individuals have signed a research directive indicating their preferencesabout future participation in research in the event that they lose decision-makingcapacity or upon death, researchers and authorized third parties should be guidedby these directives during the consent process.

Application Research directives allow individuals with decision-making capacity to expresspreferences about their future participation in research should they ever lose thiscapacity. Researchers and authorized third parties should take these directives intoaccount during the consent process, but only if the individual who provided theresearch directive lacks decision-making capacity at the time the research isinitiated. Research directives may also be used for participants who have decision-making capacity when research is initiated but lose this capacity during research.

Research directives are useful to individuals who are already participating inresearch as well as those who are not participating but may wish to participate inresearch at a later date. They give individuals a range of options regarding futureparticipation in research. The use of research directives is particularly relevant forresearch involving participants with diminishing and/or fluctuating decision-making capacity or degenerative conditions, and research that collects informationor human biological materials.

The use of research directives does not alter the requirements for consent asarticulated by the provisions of this Policy. In particular, in accordance with Article3.9, researchers are required to seek the consent of authorized third parties beforeindividuals who lack decision-making capacity can participate in research. If anindividual regains this capacity, the researcher should promptly seek the consentof the individual as a condition of continuing participation.

Researchers, institutions and organizations may suggest the use of researchdirectives in order to give participants an opportunity to express preferences aboutthe use of information or human biological material that has already been collected.Researchers who collect information or human biological materials for a specificresearch project may anticipate subsequent research uses. Some types of researchinitiatives (e.g., the creation of large databases sometimes known as researchplatforms) involve long-term retention and use of information or human biologicalmaterials for research purposes (e.g., longitudinal studies that involve biobanking).When data for these platforms are initially collected, it is not typically possible tospecify every research that could be carried out using the participants’ informationor human biological materials. Research directives may be used in these contextsto give participants the opportunity to express their preferences about futureresearch should they lose decision-making capacity (see Article 5.5A for expressionof preferences in the context of secondary use of data).



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In long-term projects, research directives may be used to allow participants to makechoices about other aspects of research participation. For example, participantscould specify preferences about receiving findings, or allowing the continued useof their information or samples in the event that they lose decision-making capacity,or after they die.

Individuals can also use research directives to express preferences concerningparticipation in future research. For example, individuals in an early stage ofcognitive impairment may use a research directive to express their preferences forfuture participation in research that, due to diminishing decision-making capacity,they would not otherwise be able to consent to on their own. They also allowexisting participants to express their preference to continue to participate in researchshould they lose decision-making capacity. Research directives should be asspecific as possible, and in the event of ambiguity or imprecision, should beinterpreted narrowly. Individuals should be encouraged to periodically update theirresearch directives and, if possible, construct directives in contemplation of specifictypes of research interventions. Research directives should be written, dated andwitnessed, and include a declaration about the decision-making capacity of theindividual at the time the directive was made.

D. Consent Shall Be Documented

Article 3.12 Evidence of consent shall be contained either in a signed consent form or indocumentation by the researcher of another appropriate means of consent.

Application Written consent in a signed statement from the participant is a common means ofdemonstrating consent, and in some instances, is mandatory (e.g., Health Canadaregulations under the Food and Drugs Act, the Civil Code of Québec). However, thereare other means of providing consent that are equally ethically acceptable. In sometypes of research, and for some groups or individuals, written signed consent may beperceived as an attempt to legalize or formalize the consent process and therefore maybe interpreted by the participant as a lack of trust on the part of the researcher. In thesecases, oral consent, a verbal agreement or a handshake may be required, rather thansigning a consent form. In some cultures, the giving and receiving of gifts symbolizesthe establishment of a relationship comparable to consent.

Where consent is not documented in a signed consent form, researchers may use arange of consent procedures, including oral consent, field notes and other strategies,for documenting the consent process. Consent may also be demonstrated solely bythe actions of the participant (e.g., through the return of a completed questionnaire).Where there are valid reasons for not recording consent in writing, the proceduresused to seek consent must be documented (see Article 10.2).


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Whether or not a consent form is signed, it may be advisable to leave a writtenstatement of the information conveyed in the consent process with the participant.For participants, it is evidence that they have agreed to participate in a particularresearch project. It may serve as a reminder to participants of the terms of theresearch project. It may also facilitate the ability of participants to consider andreconsider their involvement as the research proceeds. However, researchers shouldnot leave any documentation with participants if it may compromise their safetyor confidentiality. Additionally, in some cases it may not be appropriate to leave awritten statement, such as in cultural settings where such written documentation iscontrary to prevailing norms.

Endnote

1 For example, see Article 21 of the Civil Code of Québec, which sets conditions for the conduct ofresearch involving minors or adults who lack the capacity to consent.

References

Best Practices for Health Research Involving Children and Adolescents, Center of Genomicsand Policy, 2012.



49TCPS 2 (2014)

Chapter 4FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION

Introduction

The principle of Justice holds that particular individuals, groups or communities should neitherbear an unfair share of the direct burdens of participating in research, nor should they be unfairlyexcluded from the potential benefits of research participation. Inclusiveness in research and fairdistribution of benefits and burdens should be important considerations for researchers, researchethics boards (REBs), research institutions and sponsors. Issues of fair and equitable treatment arisein deciding whether and how to include individuals, groups or communities in research, and thebasis for the exclusion of some.

This chapter addresses inclusion in research of individuals and groups that might be inappropriatelyexcluded on the basis of attributes such as culture, language, gender, race, ethnicity, age and dis-ability. It provides guidance relevant to inclusion in research of specific groups such as women,children, the elderly and those who lack the capacity to decide whether or not to participate in re-search. Historically, these groups have often been inappropriately excluded from research.

This chapter also addresses the fair inclusion and equitable treatment of individuals, groups andcommunities whose situation or circumstances make them vulnerable in the context of a specificresearch project. These individuals run the risk of being included in research in ways that may beunfair and inequitable. This chapter provides guidance relevant to the equitable distribution of therisks and benefits of research.

Over-protectionist attitudes or practices of researchers or REBs, whether intentional or inadvertent,can exclude some members of society from participating in research. The exclusion of individuals,groups or communities may constitute a failure to treat them justly. For example, age has beenused to exclude individuals from participation in research, particularly health research (e.g., studiesthat only accept participants between the ages of 18 to 35). As a result, sufficient research maynot be done on groups that fall outside of narrow age criteria. The inclusion of the young and theelderly in research, for example, ensures that treatments frequently given to these populations areeffective and safe.

Researchers, institutions and REBs all have important roles to play in advancing that societal com-mitment, and ensuring a fair distribution of the benefits and burdens of research. Researchers andREBs must navigate between the dangers of imposing unfair burdens on particular participants,groups and communities, and overprotecting them. In assessing fairness and equity issues in theresearch ethics process, REBs should not intervene in the choice of research topics.


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Chapter 4 – Fairness and Equity in Research Participation

A. Appropriate InclusionArticle 4.1 Taking into account the scope and objectives of their research, researchers should

be inclusive in selecting participants. Researchers shall not exclude individualsfrom the opportunity to participate in research on the basis of attributes such asculture, language, religion, race, disability, sexual orientation, ethnicity, linguisticproficiency, gender or age, unless there is a valid reason for the exclusion.

Application Article 4.1 is based on the principle of Justice. It imposes a duty on researchers notto exclude individuals or groups from participation for reasons that are unrelatedto the research. This duty is explicitly stated because groups have been inappropri-ately excluded from participation in research on the basis of attributes such asgender, race, ethnicity, age and disability.

The focus, objective, nature of research and context in which the research is con-ducted inform the inclusion and exclusion criteria for a specific research project.Some research may be focused on a certain individual (such as in a biography), ora group of individuals who share a specific characteristic (e.g., an identifiable groupof painters who happen to be all of one sex; a religious order that is restricted toone sex). Other examples include research that is focused on specific cultural tra-ditions or languages, or on one age group (e.g., a biomechanical modeling studyof posture corrections in adolescents). Such research should not be precluded solong as the selection criteria for those to be included in the research are germaneto answering the research question. Researchers who plan to actively exclude par-ticular groups should clarify to their REBs the grounds for the exclusion.

Where a language barrier exists between the researcher and the prospective partic-ipant, various measures may be used to ensure effective communication inrecruitment and consent discussions. For example, an intermediary who may notbe part of the research project or team, but who is competent in the language usedby the researchers, as well as that preferred by the participant, may assist with com-munication between prospective participants and researchers. The selection of anintermediary and their activities will depend on the nature, context and risks of theresearch.

B. Inappropriate Exclusion

Research Involving Women

Women have historically been inappropriately excluded from participating in some research. Thisexclusion of women, where unwarranted, has delayed the advancement of knowledge, deniedpotential benefits to women, and exposed women to harm when research findings from male-onlyresearch projects were generalized inappropriately to women, as has often been the case in clinicaldrug trials. The inclusion of women in research advances the commitment to Justice, improvesthe generalizability of research findings to women where that is a goal of the research, and isessential to ensure that women and men benefit equally from research.


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Article 4.2 Women shall not be inappropriately excluded from research solely on the basis ofgender or sex.

Application Researchers should not exclude women from research unless there is a valid reasonfor doing so. While some research is properly focused on particular research pop-ulations that do not include women, or include very few women, women shouldgenerally be represented where there is a reasonable expectation that the results ofthe research will be generalized to women.

Article 4.2 rejects discriminatory and unethical use of inclusion or exclusion criteriathat presumptively or inappropriately exclude women because of their gender or sex.

Article 4.3 Women shall not be inappropriately excluded from research solely on the basis oftheir reproductive capacity, or because they are pregnant or breastfeeding.

Application Researchers should not exclude women from research on the basis of their repro-ductive capacity, or their pregnancy, or because they are breastfeeding, unless thereis a valid reason for doing so.

Subjecting women of childbearing potential to inappropriate requirementsprecludes their participation in research. Exclusions should be made on the basisof clear criteria that reflect balanced attention to the potential benefits as well asthe foreseeable risks of the research that may affect the welfare of women. Forexample, researchers should not require participants to use oral contraception,unless there is a valid reason for doing so.

In considering research on pregnant or breastfeeding women, researchers and REBsshall take into account foreseeable risks and potential benefits for the woman andher embryo, fetus or infant, as well as the foreseeable risks and potential benefitsof excluding pregnant or breastfeeding women from the research.

Research Involving Children

Children have varying degrees of maturity – metabolically, immunologically and cognitively –that may present important challenges for research design and the consent process, depending onthe nature and complexity of the research. In addition to the vulnerability that arises from theirdevelopmental stage, children may also lack the decision-making capacity to decide whether ornot to participate in research (see Article 4.6). As well, physical or psychological harms a childmay experience in a research setting may have long-lasting consequences. As a result, researchershave often avoided the inclusion of children in some research, especially in clinical trials testingnew treatments, so as to eliminate any risks. Clinical trials conducted only with adults yield agenerally poor understanding of the results that apply to children.

As is the case with women, the inclusion of children in research advances the commitment tojustice in research by improving our knowledge of, and ability to respond to, the unique needs ofchildren throughout their development.



Article 4.4 Children shall not be inappropriately excluded from research solely on the basis oftheir age or developmental stage. The inclusion of children in research is subjectto Article 4.6.

Application Researchers should not exclude children from research unless there is a valid reasonfor doing so. Participation of children in research is justifiable when the researchobjective cannot be achieved with adult participants only. When considering theinclusion of children in research, researchers and REBs shall consider a child’sstage of physical, physiological, psychological, and social development to ensureadequate protections for the child’s welfare. Where children have not yet attainedthe capacity to decide for themselves whether or not to participate in research,researchers shall seek consent from an authorized third party while ascertainingthe child’s assent or dissent, as outlined in Chapter 3. Note that Article 4.6 equallyapplies to children.

Research Involving the Elderly

As the population ages, the proportion of elderly people is increasing, and so is their life ex-pectancy. Research designed to improve our understanding of a wide range of aspects of agingand the lives of elderly people is important for ensuring that they stay fully integrated into societyand maintain a continuing high quality of life. Medically, elderly patients are the highest consumersof drugs, yet many of these treatments have not been tested adequately on elderly patients. Re-search that takes into account the differential effects on the elderly and how best to accommodatetheir needs provides scientific evidence that can inform changes to policies and standards of carefor the elderly.

Article 4.5 Elderly people shall not be inappropriately excluded from research solely on thebasis of their age.

Application Researchers should not exclude elderly people from research unless there is a validreason for doing so. When considering the inclusion of elderly people in research,researchers and REBs shall consider their physical and social needs to ensureadequate protections. Depending on their social circumstances, elderly people mayrequire some reasonable accommodation for mobility, transportation support andother types of assistance to facilitate their participation in research. The principleof Justice requires that such accommodations for the natural processes of aging beconsidered by REBs and researchers. Exclusion of the elderly shall not be basedon easily remediable issues that are not germane to the research question.

Research Involving Participants Who Lack Decision-Making Capacity

The core principles of Justice and Concern for Welfare entail special ethical obligations towardindividuals who lack capacity to decide whether or not to participate in research. This section setsout conditions that apply to research involving those who cannot consent for themselves due to alack of decision-making capacity. It should be read in conjunction with Section C of Chapter 3.

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Article 4.6 Subject to applicable legal requirements, individuals who lack capacity to decidewhether or not to participate in research shall not be inappropriately excluded fromresearch. Where a researcher seeks to involve individuals in research who do nothave decision-making capacity, the researcher shall, in addition to fulfilling theconditions in Articles 3.9 and 3.10, satisfy the REB that:

(a) the research question can be addressed only with participants within the iden-tified group; and

(b) the research does not expose the participants to more than minimal risk withoutthe prospect of direct benefits for them; or

(c) where the research entails only minimal risk, it should at least have the prospectof providing benefits to participants or to a group that is the focus of the re-search and to which the participants belong.

Application Children, and individuals with cognitive impairments or intellectual disabilitiesmay lack the capacity to decide whether or not to participate in particular researchinitiatives. As a result, they have, historically, experienced both over-inclusion aspopulations of convenience for some research and unjustified exclusion from otherresearch. Yet the advancement of knowledge about their social, psychological, andhealth experiences and needs may depend on their appropriate participation inresearch. Their inclusion in research requires special considerations as outlined inthis article.

To be ethically acceptable, the participation of those who lack the capacity to decidefor themselves shall be necessary and appropriate to address the research question.Researchers and REBs shall consider the level of risk to which participants wholack decision-making capacity are exposed, and the prospect of direct benefitsaccruing to the participants. Their participation should generally be limited toresearch of minimal risk as defined in this Policy (see Chapter 2 for the definitionof minimal risk).

Where the research presents more than minimal risk, it should have appropriatejustification aimed at generating knowledge of sufficient importance to addressingthe participants’ disorder, condition, interest or situation. Such research should havethe prospect of direct benefits for the participants themselves commensurate withthe level of foreseeable risk to participants. The relation of the potential benefit tothe foreseeable risk presented by the research should be at least as favourable tothe participants as that provided by available alternative approaches.

Where the research entails only minimal risk, it is sufficient if the research presentsthe prospect of benefits to participants or to a group that is the focus of the researchand to which the participants belong.

The research design should take into account factors that may affect the decision-making capacity of prospective participants to receive information, to consent to

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the research at some stage, or to participate in it. These factors may be permanentor may vary over time (e.g., the participant’s decision-making capacity mayfluctuate over time). Articles 3.9 and 3.10 in Chapter 3 establish other conditionsregarding research that involve individuals who lack decision-making capacity.This includes the involvement of an authorized third party to consent on theirbehalf, and adequate provisions to ascertain the wishes of the individualsconcerning their participation.

Participants’ Vulnerability and Research

Article 4.7 Individuals or groups whose circumstances may make them vulnerable in the con-text of research should not be inappropriately included or automatically excludedfrom participation in research on the basis of their circumstances.

Application The core principles of Respect for Persons, Concern for Welfare, and Justice entailspecial ethical obligations toward individuals or groups whose circumstances maylead to their vulnerability in the context of a specific research project and limit theirability to fully safeguard their own interests. Those who are owed special ethicalobligations may include individuals who are institutionalized, those in dependentsituations, or those whose circumstances (e.g., poverty or poor health status) mayrender even modest participation incentives so attractive as to constitute an induce-ment to take risks they would otherwise not take. Their situation may alsocompromise the voluntariness of consent in other ways. However, individualsshould not automatically be considered vulnerable simply because of assumptionsmade about the vulnerability of the group to which they belong. Their particularcircumstances shall be considered in the context of the proposed research project.

REBs and researchers shall carefully examine the relationship between the circum-stances of the individuals and groups they aim to recruit, and the proposed researchquestion. They should not presume that these circumstances will automatically re-sult in the inclusion or exclusion of individuals or groups as prospectiveparticipants. Participation should be based on inclusion or exclusion criteria thatare justified by the research question. Researchers and REBs should recognize andaddress changes in a participant’s circumstances that may create, heighten, or at-tenuate their vulnerability, and provide special protections or consideration.

In general, researchers should be familiar with the cultural, social and economiccircumstances of prospective participants, groups or communities. Researchersshould anticipate, to the best of their ability, needs of participants, groups and theircommunities that might arise in any given research project. Especially when groups,and their communities, have a wide range of pressing needs due to their low so-cioeconomic circumstances, these needs can present significant ethical challengesfor researchers. An equitable distribution of research benefits (discussed below)can help ensure that individuals, groups and communities whose circumstancesmay make them vulnerable in the context of research are not inappropriately in-cluded in research based on these circumstances.

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Equitable Distribution of Research Benefits

Researchers should consider ways to ensure the equitable distribution of any benefits of partici-pation in research. Benefits of research participation may be direct, where, for example, anindividual participant experiences amelioration of a health condition as a result of an experimentaltherapy, or learns new information about social issues as a result of participation in a researchfocus group. In a community hosting research, benefits may take the form of information sharing,training for local personnel, the establishment of health care or similar services. Benefits may beindirect, where the participation in research of an individual or group, or in a research project in-volving a community contributes to the advancement of knowledge that may lead to improvedconditions for a group to which the participant belongs. Such knowledge may also inform othercommunities or society in general.

Researchers should also be sensitive to the expectations and opinions of participants regardingpotential benefits of the research. Prior to the commencement of the research, researchers shouldformally or informally discuss these expectations with individuals and/or groups, and outline thescope and nature of potential benefits that may accrue to participants during and after the research(see Article 9.13). REBs should be vigilant to ensure that the proposed distribution of benefits isfair, without imposing undue burdens on the researcher that would make it too difficult or costlyto complete research.

Researchers should normally provide copies of publications, or other research reports or products,arising from the research to the institution or organization – normally the host institution – that isbest suited to act as a repository and disseminator of the results within the participating commu-nities. This may not be necessary in jurisdictions where the results are readily available in print orelectronically. In general, researchers should ensure that participating individuals, groups and com-munities are informed of how to access the results of the research. Results of the research shouldbe made available to them in a culturally appropriate and meaningful format, such as reports inplain language in addition to technical reports.

References


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Chapter 5PRIVACY AND CONFIDENTIALITY

Introduction

There is widespread agreement about the interests of participants in protection of privacy, and thecorresponding duties of researchers to treat personal information in a confidential manner. Indeed,the respect for privacy in research is an internationally recognized norm and ethical standard.Fundamental rights and freedoms in the Canadian Constitution have been interpreted by the courtsto include privacy protections. Privacy rights are protected in federal and provincial/territoriallegislation. Model voluntary codes1 have also been adopted to govern access to, and the protectionof, personal information. Some professional organizations have established codes that set out theconditions and obligations of their members regarding the collection, use and disclosure of personalinformation.

Privacy risks in research relate to the identifiability of participants, and the potential harms they,or groups to which they belong, may experience from the collection, use and disclosure of personalinformation. Privacy risks arise at all stages of the research life cycle, including initial collectionof information, use and analysis to address research questions, dissemination of findings, storageand retention of information, and disposal of records or devices on which information is stored.

This Policy is based on a proportionate approach to the assessment of the ethical acceptability ofresearch. Researchers and research ethics boards (REBs) are expected to identify and minimizeprivacy risks, keeping in mind that a matter that is not sensitive or embarrassing for the researchermay be so for the participant.

In addition to following the guidance provided in this Policy, researchers are responsible forcompliance with all applicable legal and regulatory requirements with respect to protection ofprivacy, and consent for the collection, use or disclosure of information about participants. Theserequirements may vary by jurisdiction and, depending on who is funding or conducting theresearch, may include obligations under the Constitution (including the Canadian Charter of Rightsand Freedoms), and federal or provincial privacy legislation, among other legal and regulatoryrequirements.

A. Key Concepts

Privacy

Privacy refers to an individual’s right to be free from intrusion or interference by others. It is afundamental right in a free and democratic society. Individuals have privacy interests in relationto their bodies, personal information, expressed thoughts and opinions, personal communicationswith others, and spaces they occupy. Research affects these various domains of privacy in different

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ways, depending on its objectives and methods. An important aspect of privacy is the right to con-trol information about oneself. The concept of consent is related to the right to privacy. Privacy isrespected if an individual has an opportunity to exercise control over personal information by con-senting to, or withholding consent for, the collection, use and/or disclosure of information (seeChapter 3 for further discussion of consent).

Confidentiality

The ethical duty of confidentiality refers to the obligation of an individual or organization to safe-guard entrusted information. The ethical duty of confidentiality includes obligations to protectinformation from unauthorized access, use, disclosure, modification, loss or theft. Fulfilling theethical duty of confidentiality is essential to the trust relationship between researcher and partici-pant, and to the integrity of the research project.

Security

Security refers to measures used to protect information. It includes physical, administrative andtechnical safeguards. An individual or organization fulfils its confidentiality duties, in part, byadopting and enforcing appropriate security measures. Physical safeguards include the use oflocked filing cabinets, and the location of computers containing research data away from publicareas. Administrative safeguards include the development and enforcement of organizational rulesabout who has access to personal information about participants. Technical safeguards include useof computer passwords, firewalls, anti-virus software, encryption and other measures that protectdata from unauthorized access, loss or modification.

Identifiable Information

Where researchers seek to collect, use, share and access different types of information or dataabout participants, they are expected to determine whether the information or data proposed inresearch may reasonably be expected to identify an individual. For the purposes of this Policy,researchers and REBs shall consider whether information is identifiable or non-identifiable.Information is identifiable if it may reasonably be expected to identify an individual, when usedalone or combined with other available information. Information is non-identifiable if it does notidentify an individual, for all practical purposes, when used alone or combined with other availableinformation. The term “personal information” generally denotes identifiable information about anindividual. The assessment of whether information is identifiable is made in the context of aspecific research project.

Types of Information

Researchers may seek to collect, use, share and access different types of information about par-ticipants. Such information may include personal characteristics or other information about whichan individual has a reasonable expectation of privacy (e.g., age, ethnicity, educational background,employment history, health history, life experience, religion, social status).

For the purposes of this Policy, researchers and REBs shall consider whether information proposedfor use in research is identifiable. The following categories provide guidance for assessing theextent to which information could be used to identify an individual:

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Chapter 5 – Privacy and Confidentiality


• Directly identifying information – the information identifies a specific individual throughdirect identifiers (e.g., name, social insurance number, personal health number).

• Indirectly identifying information – the information can reasonably be expected to iden-tify an individual through a combination of indirect identifiers (e.g., date of birth, placeof residence or unique personal characteristic).

• Coded information – direct identifiers are removed from the information and replacedwith a code. Depending on access to the code, it may be possible to re-identify specificparticipants (e.g., the principal investigator retains a list that links the participants’ codenames with their actual name so data can be re-linked if necessary).

• Anonymized information – the information is irrevocably stripped of direct identifiers,a code is not kept to allow future re-linkage, and risk of re-identification of individualsfrom remaining indirect identifiers is low or very low.

• Anonymous information – the information never had identifiers associated with it (e.g.,anonymous surveys) and risk of identification of individuals is low or very low.

Ethical concerns regarding privacy decrease as it becomes more difficult (or impossible) to asso-ciate information with a particular individual. These concerns also vary with the sensitivity of theinformation and the extent to which access, use or disclosure may harm an individual or group.

The easiest way to protect participants is through the collection and use of anonymous oranonymized data, although this is not always possible or desirable. For example, after informationis anonymized, it is not possible to link new information to individuals within a dataset, or toreturn results to participants. A “next best” alternative is to use de-identified data: the data are pro-vided to the researcher in de-identified form and the existing key code is accessible only to acustodian or trusted third party who is independent of the researcher. The last alternative is for re-searchers to collect data in identifiable form and take measures to de-identify the data as soon aspossible. Although these measures are effective ways to protect participants from identification,the use of indirectly identifying, coded, anonymized or anonymous information for research maystill present risks of re-identification.

Technological developments have increased the ability to access, store and analyze large volumesof data. These activities may heighten risks of re-identification, such as when researchers linkdatasets (see Section E, this chapter), or where a dataset contains information about a populationin a small geographical area, or about individuals with unique characteristics (e.g., uncommonfield of occupational specialization, diagnosis of a very rare disease). Various factors can affectthe risks of re-identification, and researchers and REBs should be vigilant in their efforts to rec-ognize and reduce these risks. Data linkage of two or more datasets of anonymous informationmay present risks of identification (see Article 2.4 or Article 9.22).

Where it is not feasible to use anonymous or anonymized data for research (and there are manyreasons why data may need to be gathered and retained in an identifiable form), the ethical dutyof confidentiality and the use of appropriate measures to safeguard information become para-mount. This Policy generally requires more stringent protections in research involving identifiable

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information. Researchers are expected to consult their REB if they are uncertain about whetherinformation proposed for use in research is identifiable (e.g., when proposing to link anonymizedor coded datasets).

B. Ethical Duty of Confidentiality

Article 5.1 Researchers shall safeguard information entrusted to them and not misuse orwrongfully disclose it. Institutions shall support their researchers in maintainingpromises of confidentiality.

Application When researchers obtain information with a promise of confidentiality, they assumean ethical duty that is central to respect for participants and the integrity of the re-search project. Breaches of confidentiality may harm the participant, the trustrelationship between the researcher and the participant, other individuals or groups,and/or the reputation of the research community. Research that probes sensitivetopics (e.g., illegal activities) generally depends on strong promises of confiden-tiality to establish trust with participants.

The ethical duty of confidentiality applies to information obtained directly fromparticipants, or from other researchers or organizations that have legal, professionalor other obligations to maintain confidentiality.

The ethical duty of confidentiality must, at times, be balanced against competingethical considerations or legal or professional requirements that call for disclosureof information obtained or created in a research context. For example, in excep-tional and compelling circumstances, researchers may be subject to obligations toreport information to authorities to protect the health, life or safety of a participantor a third party. Researchers are expected to be aware of ethical codes (such as pro-fessional codes of conduct) or laws (e.g., those requiring the reporting of childrenin need of protection) that may require disclosure of information they obtain in aresearch context. In other situations, a third party may seek access to informationobtained and/or created in confidence in a research context. An access request mayseek voluntary disclosure of information, or may seek to compel disclosure throughforce of law (e.g., by subpoena). Chapter 1, Section C, elaborates on the relationshipbetween research ethics and law.

Certain areas of research (such as research involving children at risk of abuse orstudies of criminal behaviour) are more likely to put researchers in positions wherethey may experience tension between the ethical duty of confidentiality anddisclosure to third parties. Researchers shall maintain their promise ofconfidentiality to participants within the extent permitted by ethical principlesand/or law. This may involve resisting requests for access, such as opposing courtapplications seeking disclosure. Researchers’ conduct in such situations should beassessed on a case-by-case basis and guided by consultation with colleagues, anyrelevant professional body, the REB and/or legal counsel.

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In some instances, participants may waive anonymity (e.g., if they wish to be iden-tified for their contributions to the research). Researchers should obtain the consentof these participants, and negotiate agreements with them that specify how theymay be identified or recognized for their contribution. Where an individual partic-ipant waives anonymity but other members of the participant group object becauseidentification may cause harm to the group, researchers shall maintain anonymityfor all members of the participant group (see Article 3.2[f] and Article 10.4).

Article 5.2 Researchers shall describe measures for meeting confidentiality obligations andexplain any reasonably foreseeable disclosure requirements:

(a) in application materials they submit to the REB; and

(b) during the consent process with prospective participants.

Application This article recognizes that some research projects are more likely to put researchersin a position where they may have a requirement to disclose information to thirdparties. The reasonable foreseeability of disclosure requirements can be assessedby considering the nature and objectives of the research inquiry. For example, re-search that involves interviewing high-risk families about intergenerationalviolence raises a reasonably foreseeable prospect that researchers may acquire in-formation that a child is being abused. Researchers who reasonably foresee thattheir inquiries may give rise to an ethical or legal reason to disclose informationobtained in the research context shall advise the REB and prospective participantsabout the possibility of compelled disclosure. Advising participants of reasonablyforeseeable disclosure requirements is an important aspect of the consent process.

Situations may arise where researchers unexpectedly acquire information that givesrise to a reason for disclosure to a third party, or researchers may receive a disclo-sure demand from a third party. In such cases, advising a participant about thedisclosure may be important to respect the trust relationship with the participant,and to ensure the validity of the participant’s ongoing consent. Decisions aboutwhether, how and when to advise a participant of disclosure should be guided byany applicable disciplinary standards and consultation with the REB, colleagues,relevant professional body and/or legal counsel.

Researchers shall also inform participants and seek their consent if their personalinformation may be shared with government departments or agencies, communitypartners in the research, personnel from an agency that monitors the research, aresearch sponsor (such as a pharmaceutical company), the REB or a regulatoryagency.

Researchers shall avoid being put in a position of becoming informants forauthorities or leaders of organizations. For example, when records of prisoners,employees, students or others are used for research purposes, the researcher shallnot provide authorities with results that could identify individuals unless the priorwritten consent of the participants has been given. Researchers may, however,

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provide administrative bodies with aggregated data that cannot be linked toindividuals for purposes such as policy-making or program evaluation. Whenseeking consent, researchers shall advise prospective participants if aggregated datafrom a project may be disclosed, particularly where such disclosure may pose arisk to the participants. For example, aggregate data provided to authorities aboutresearch on illicit drug use in a penitentiary may pose risks of reprisal to theprisoners, even though they are not identified individually.

When planning a study, researchers should incorporate any applicable statute-basedor other legal principles that may afford protection for the privacy of participantsand the confidentiality of research information.

C. Safeguarding Information

Article 5.3 Researchers shall provide details to the REB regarding their proposed measures forsafeguarding information, for the full life cycle of information: its collection, use,dissemination, retention and/or disposal.

Application Researchers shall assess privacy risks and threats to the security of information forall stages of the research life cycle, and implement appropriate measures to protectinformation. Safeguarding information helps respect the privacy of participants andhelps researchers fulfil their confidentiality obligations. In adopting measures tosafeguard information, researchers should follow disciplinary standards and prac-tices for the collection and protection of information gathered for research purposes.Formal privacy impact assessments are required in some institutions and may alsobe required under legislation or policy in some jurisdictions. Security measuresshould take into account the nature, type and state of data: the data’s form (e.g.,paper or electronic records); content (e.g., presence of direct or indirect identifiers);mobility (e.g., kept in one location or subject to physical or electronic transport);and vulnerability to unauthorized access (e.g., use of encryption or password pro-tection). Measures for safeguarding information apply both to original documentsand copies of information.

Factors relevant to the REB’s assessment of the adequacy of the researchers’ pro-posed measures for safeguarding information include:

(a) the type of information to be collected;

(b) the purpose for which the information will be used, and the purpose of anysecondary use of identifiable information;

(c) limits on the use, disclosure and retention of the information;

(d) risks to participants should the security of the data be breached, includingrisks of re-identification of individuals;

(e) appropriate security safeguards for the full life cycle of information;

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(f) any recording of observations (e.g., photographs, videos, sound recordings)in the research that may allow identification of particular participants;

(g) any anticipated uses of personal information from the research; and

(h) any anticipated linkage of data gathered in the research with other data aboutparticipants, whether those data are contained in public or personal records(see also Section E of this chapter).

In considering the adequacy of proposed measures for safeguarding informationduring its full life cycle, REBs should not automatically impose a requirement thatresearchers destroy the research data. Stored information may be useful for a varietyof future purposes. Appropriate data retention periods vary depending on the re-search discipline, research purpose and the kind of data involved. In somesituations, formal data sharing with participants may occur, for example, by givingindividual participants copies of a recording or transcript as a gift for personal,family or other archival use. Similarly, some funding bodies, such as the SocialSciences and Humanities Research Council and the Canadian Institutes of HealthResearch, have specific policies on data archiving and sharing.2 Researchers shouldaddress how participants’ information will be handled if participants choose towithdraw from the research.

In disseminating findings, researchers shall not disclose identifiable informationwithout the consent of participants. In the case of critical inquiry research, identi-fiable information may be revealed about any objects of the inquiry as they areusually not regarded as participants (see Article 3.6). Researchers shall take rea-sonable measures to avoid inadvertent identification of individuals or groups inpublications or other means of dissemination – and they must address this issue tothe satisfaction of the REB.

Consideration of future uses of personal information refers not just to research, butalso to other purposes, such as the future use of research materials for educationalpurposes.

Research data sent over the Internet may require encryption or use of special de-nominalization software to prevent interception by unauthorized individuals, orother risks to data security. In general, identifiable data obtained through researchthat is kept on a computer and connected to the Internet should be encrypted.

Article 5.4 Institutions or organizations where research data are held have a responsibility toestablish appropriate institutional security safeguards.

Application In addition to the security measures researchers implement to protect data,safeguards put in place at the institutional or organizational level also provideimportant protection. These data security safeguards should include adequatephysical, administrative and technical measures, and should address the full life

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cycle of information. This includes institutional or organizational safeguards forinformation while it is currently in use by researchers, and for any long-termretention of information.

D. Consent and Secondary Use of Identifiable Information for Research Purposes

Secondary use refers to the use in research of information originally collected for a purpose otherthan the current research purpose. Common examples are social science or health survey datasetsthat are collected for specific research or statistical purposes, but then re-used to answer otherresearch questions. Information initially collected for program evaluation may be useful forsubsequent research. Other examples include health care records, school records, biologicalspecimens, vital statistics registries or unemployment records, all of which are originally createdor collected for therapeutic, educational or administrative purposes, but which may be sought laterfor use in research. Chapter 12 provides further guidance on research involving secondary use ofpreviously collected biological materials.

Reasons to conduct secondary analyses of data include: avoidance of duplication in primarycollection and the associated reduction of burdens on participants; corroboration or criticism ofthe conclusions of the original project; comparison of change in a research sample over time;application of new tests of hypotheses that were not available at the time of original data collection;and confirmation that the data are authentic. Privacy concerns and questions about the need toseek consent arise, however, when information provided for secondary use in research can belinked to individuals, and when the possibility exists that individuals can be identified in publishedreports, or through data linkage (Article 5.7). Privacy legislation recognizes these concerns andpermits secondary use of identifiable information under certain circumstances.

Article 5.5A Researchers who have not obtained consent from participants for secondary use ofidentifiable information shall only use such information for these purposes if theyhave satisfied the REB that:

(a) identifiable information is essential to the research;

(b) the use of identifiable information without the participants’ consent is unlikelyto adversely affect the welfare of individuals to whom the information relates;

(c) the researchers will take appropriate measures to protect the privacy ofindividuals, and to safeguard the identifiable information;

(d) the researchers will comply with any known preferences previously expressedby individuals about any use of their information;

(e) it is impossible or impracticable (see Glossary) to seek consent from individ-uals to whom the information relates; and

(f) the researchers have obtained any other necessary permission for secondaryuse of information for research purposes.


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If a researcher satisfies all the conditions in Article 5.5A(a) to (f), the REB mayapprove the research without requiring consent from the individuals to whom theinformation relates.

Application In the case of secondary use of identifiable information, researchers must obtainconsent unless the researcher satisfies all the requirements in Article 5.5A.

The exception to the requirement to seek consent in this article is specific to sec-ondary use of identifiable information. The terms of Article 3.7A address alterationof consent in other circumstances and do not apply here.

Secondary use of information identifiable as originating from a specific Aboriginalcommunity, or a segment of the Aboriginal community at large, is addressed inArticles 9.20 to 9.22.3

“Impracticable” refers to undue hardship or onerousness that jeopardizes theconduct of the research; it does not mean mere inconvenience (see Glossary).Consent may be impossible or impracticable when the group is very large or itsmembers are likely to be deceased, geographically dispersed or difficult to track.Attempting to track and contact members of the group may raise additional privacyconcerns. Financial, human and other resources required to contact individuals andseek consent may impose undue hardship on the researcher. In some jurisdictions,privacy laws may preclude researchers from using personal information to contactindividuals to seek their consent for secondary use of information.4

The researcher must respect relevant privacy laws, regulations and institutionalpolicies and may be required to consult with or obtain approval from appropriatedata stewards. Privacy laws may impose specific rules regarding disclosure ofinformation for secondary use in research. These laws may require the individualor organization that has custody or control of requested personal information toobtain approval from a privacy commissioner or other body before disclosinginformation to researchers. They may also impose additional requirements such asinformation-sharing agreements that describe disclosure conditions. Theserequirements may include the stipulation that the researcher not publish identifiableinformation or contact individuals to whom the information relates.

At the time of initial collection, individuals may have had an opportunity to expresspreferences about future uses of information, including research uses (see paragraph[d] in the Application of Article 3.2). Data stewards have an obligation to respectthe individual’s expressed preferences. For example, where an individual does notwant information used for future research, data stewards shall remove this infor-mation from any datasets used or made available for research.

In cases where the proposed research involves information of greater sensitivity(e.g., genetic information, information about individuals who seek help throughdomestic violence shelters, information about sexual practices), the REB may

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require that researchers engage in discussion with people whose perspectives canhelp identify the ethical implications of the research, and suggest ways to minimizeany associated risks. Discussion is not intended to serve as proxy consent. Rather,a goal of discussion is to seek input regarding the proposed research, such as thedesign of the research, measures for privacy protection, and potential uses offindings. Discussion may also be useful to determine whether or not the researchwill adversely affect the welfare of individuals to whom the information relates.Researchers shall advise the REB of the outcome of such discussions. The REBmay require modifications to the research proposal based on these discussions.

Article 5.5B Researchers shall seek REB review, but are not required to seek participant consent,for research that relies exclusively on the secondary use of non-identifiableinformation.

Application The onus will be on the researcher to establish to the satisfaction of the REB that,in the context of the proposed research, the information to be used can be considerednon-identifiable for all practical purposes. For example, the secondary use of codedinformation may identify individuals in research projects where the researcher hasaccess to the key that links the participants’ codes with their names. Consent wouldbe required in this situation. However, the same coded information may be assessedas non-identifiable in research projects where the researcher does not have accessto the key. Consent would not be required in this situation.

Article 5.6 When secondary use of identifiable information without the requirement to seekconsent has been approved under Article 5.5A, researchers who propose to contactindividuals for additional information shall, prior to contact, seek REB approval ofthe plan for making contact.

Application In certain cases, a research goal may be achieved only through follow up contactwith individuals to collect additional information. Under Article 5.5A, the REBmay have approved secondary use without the requirement to seek consent, based,in part, on the impossibility or impracticability of seeking consent from allindividuals whose information is proposed for use in research. Where contact witha sub-group is feasible, researchers may subsequently wish to attempt to makecontact with some individuals to obtain additional information. Contact withindividuals whose previously collected information has been approved forsecondary use in research raises privacy concerns. Individuals might not want tobe contacted by researchers or might be upset that identifiable information wasdisclosed to researchers without their consent. The potential benefits of follow-upcontact must clearly outweigh the risks to individuals of follow-up contact, and theREB must be satisfied that the proposed manner of follow-up contact minimizesrisks to individuals. The proposed plan shall explain who will contact individualsto invite their participation in the research (e.g., a representative of the organizationthat holds the individual’s information) and the nature of their relationship with

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those individuals. Researchers shall also ensure that a plan for follow-up contactcomplies with applicable privacy legislation. For example, some privacy lawsprohibit researchers from contacting individuals unless the custodian of theinformation has first sought and obtained individuals’ consent to be contacted.Whenever possible, it is preferable that re-contact with participants be carried outby the custodian of the original data set. Researchers will need to seek consent fromindividual participants for any new data collection. Article 3.1 provides furtherguidance on consent and approaches to recruitment.

E. Data Linkage

Article 5.7 Researchers who propose to engage in data linkage shall obtain REB approval priorto carrying out the data linkage, unless the research relies exclusively on publiclyavailable information as discussed in Article 2.2. The application for approval shalldescribe the data that will be linked and the likelihood that identifiable informationwill be created through the data linkage.

Where data linkage involves or is likely to produce identifiable information, re-searchers shall satisfy the REB that:

(a) the data linkage is essential to the research; and

(b) appropriate security measures will be implemented to safeguard information.

Application Growing numbers of databases and advancing technological capacity to link data-bases create new research opportunities, but also new privacy risks. In particular,linkage of de-identified or anonymized databases may permit re-identification ofindividuals. This article provides guidance for researchers who propose to carry outdata linkage and requires that they assess and minimize risks of re-identification.Only a restricted number of individuals should perform the function of mergingdatabases. Researchers should use enhanced security measures to store the mergedfile.

Where researchers seek access to datasets held by another organization, it may bepreferable for the data holder to carry out the data linkage and remove identifiersbefore disclosing the merged dataset.

Legislation and organizational policies may regulate data linkage in specificcircumstances. For example, some personal information protection legislationrequires data-sharing agreements that regulate conditions under which data linkagemay be carried out. Data holders, such as statistics agencies, may also have policieson data linkage.5

Where researchers propose to access and link datasets of identifiable informationfor the secondary purpose of research, the requirements of Section D apply.

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Endnotes

1 See, for example, Canadian Standards Association, Model Code for the Protection of PersonalInformation (1996).2 See the Social Sciences and Humanities Research Council, “Research Data Archiving Policy” and theCanadian Institutes of Health Research “Open Access Policy” (January 2013) and the Canadian Institutesof Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences andHumanities Research Council of Canada, Access to Research Results: Guiding Principles. 3 See also the Canadian Institutes of Health Research, CIHR Guidelines for Health Research InvolvingAboriginal People (May 2007).4 For discussion of factors relevant to assessing impracticability of consent, see, for example, theCanadian Institutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research,Section 3.3, Secondary Use (September 2005).5 See, for example, Statistics Canada, “Policy on Record Linkage.”

References


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Chapter 6GOVERNANCE OF RESEARCH ETHICS REVIEW

Introduction

This chapter sets out the elements of research ethics review including the procedures necessary toestablish a research ethics board (REB), and operational guidelines for the REBs and researchethics review, both initially and throughout the course of the research project. It also includesguidelines for the conduct of research ethics review during publicly declared emergencies.

A key goal in establishing an appropriate governance structure for research ethics review is to en-sure that REBs operate with a clear mandate, authority and accountability; and that roles andresponsibilities are clearly defined. REBs need independence in their decision-making process tocarry out their role effectively, and to properly apply the core principles of this Policy – Respectfor Persons, Concern for Welfare and Justice – to their ethics review of research projects. Theseoperational guidelines are meant to be flexible enough to apply in various contexts, at institutionsof various sizes, and to the full range of research disciplines, fields and methodologies.

A. Establishment of Research Ethics Boards

Authority, Mandate and Accountability

Article 6.1 Institutions shall establish or appoint REB(s) to review the ethical acceptability ofall research involving humans conducted within their jurisdiction or under theirauspices, that is, by their faculty, staff or students, regardless of where the researchis conducted, in accordance with this Policy.

Application Each institution is accountable for the research carried out in its own jurisdictionor under its auspices. In fulfilling this responsibility, where research involving hu-mans takes place within the jurisdiction or under the auspices of an institution, thatinstitution shall establish the necessary structure of an REB (or REBs) capable ofreviewing the ethical acceptability of that research. In fulfilling this responsibility,institutions may opt to appoint an external REB in accordance with the Agreementbetween the Agencies and institutions.1 Any such appointment should be based onan official agreement clarifying the ultimate responsibility of the institution for theethical acceptability of research undertaken within its jurisdiction or under its aus-pices. To demonstrate their accountability, institutions may wish to issue publicreports summarizing the institution’s activities and initiatives relevant to the ethicsreview of research involving humans, its research ethics administration, and rele-vant research ethics education and training.

The number of REBs and the expertise of their members will depend on the rangeand volume of research for which that institution is responsible, in accordance with

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Articles 6.4 and 6.5 relating to REB composition. Large institutions may find itnecessary to create more than one REB to cover different areas of research or toaccommodate a large volume of research. Small institutions may wish to exploreregional cooperation or alliances for access to an REB based on formal agreementsbetween the institutions (see Article 8.1).

Members of an institution (i.e., its faculty, staff and students) may be affiliated withother institutions, or may be engaged in consulting or other professional activitiesin a separate enterprise, or in student co-op work or field placements. If membersof the institution make reference to their affiliation to the institution, or use any ofits resources when engaging in research, they should submit their research proposalto their institutional REB for research ethics review in accordance with this Policy.Where student co-op work or field placements involve components of research thatrequire research ethics review, institutions and organizations hosting co-op studentresearchers may consider specifying in advance (e.g., in policies, agreements orcontracts for co-op student placements) the roles and responsibilities pertaining tothe ethics review of research involving humans of the host organization versusthose of the institution.

Should the institution determine that some situations warrant an exception to therequirement for REB review, the basis and conditions for case-by-case exceptionsshall be clearly documented in the institutional policies. Case-by-case exceptionsmay be determined by such factors as the degree to which the members’ affiliationwith the institution is their primary affiliation, or by how practical it is to distinguishthe capacity in which the member is conducting the research, and the participants’reasonable perceptions of this capacity. Other factors include the availability ofother avenues through which the member may address the guidance in this Policyoutside the institution, including the possibility of sharing responsibility for re-search ethics review, and the methods in place to address real, potential or perceivedconflict of interest issues.

Article 6.2 The highest body within an institution shall: establish the REB or REBs, define anappropriate reporting relationship with the REBs, and ensure the REBs are providedwith necessary and sufficient ongoing financial and administrative resources to ful-fil their duties. REBs are independent in their decision making and are accountableto the highest body that established them for the process of research ethics review.

Application The highest body of the institution that establishes the REB or REBs could be anindividual, such as the president, rector or chief executive officer, or an equivalentbody, such as a governing council, board of directors, or council of administration.Institutions determine the highest body based on their individual governancestructures and taking into consideration whether other responsibilities of thosebodies may conflict with the responsibility for establishing an REB. Institutionsshall have in place written procedures for the appointment, renewal and removalof REB members, including Chairs.

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Chapter 6 – Governance of Research Ethics Review


For the integrity of the research ethics review process, and to safeguard public trustin that process, institutions shall ensure that REBs are able to operate effectivelyand independently in their decision making. Disagreement between the researcherand the REB over a decision that cannot be resolved through discussion andreconsideration can be resolved through the normal appeal process (see Articles6.18 to 6.20).

Institutional policies and procedures shall also support and promote the independ-ence of REBs in their decision making so that REBs may be free of inappropriateinfluence, including situations of real, potential or perceived conflicts of interest(see Chapter 7).

It is critical that institutions provide appropriate administrative resources to REBs(e.g., research ethics administration staff, a research ethics office) for the effectiveand efficient operation of the REB. The means by which this support may be pro-vided will vary by institution, but may include REB coordination, support in policydevelopment and interpretation, record keeping, and provision of research ethicstraining opportunities to REB members, researchers and students. The researchethics administration staff may provide important ethics expertise in support of theREB’s ethical analysis and discussion. Research ethics administration staff shouldalso have the necessary qualifications, as well as initial and continuing training, toappropriately perform their roles and responsibilities. Institutions should recognizethe integral role of research ethics administration staff and research ethics office(s),as applicable, in supporting the REB in fulfilling its mandate.

As an entity that draws its authority and resources from the institution, the REBremains accountable to the highest body of the institution that established it for theintegrity of its processes.

Article 6.3 The institution shall grant the REB the mandate to review the ethical acceptabilityof research on behalf of the institution, including approving, rejecting, proposingmodifications to, or terminating any proposed or ongoing research involving hu-mans. This mandate shall apply to research conducted under the auspices or withinthe jurisdiction of the institution, using the considerations set forth in this Policy.

Application The institution shall delegate to the REB the authority to review the ethical accept-ability of research through its normal process of governance. In defining the scopeof the REB’s mandate, the institution shall clearly define the jurisdiction of theREB to cover a range of research consistent with relevant disciplinary competenceand a manageable workload. Where the institution requires more than one REB, itshould establish a mechanism to coordinate the operations of all its REBs, and clar-ify their relationship with each other, and with other relevant bodies or authorities.Institutions shall have clear written policies describing the mandate of each REB.An institution may wish to use different models for the ethics review of researchconducted under its auspices (see Chapter 8).

Institutions shall respect the authority delegated to the REB. An institution may

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not override an REB decision to reject a research proposal. An appeal of the REBdecision to reject a research proposal can only be brought in accordance withSection C of this chapter.

An REB approval applies to the ethical acceptability of the research, and does not,in itself, constitute authorization for the research to proceed.

REB Composition

Basic REB Membership Requirements

The membership of the REB is designed to ensure competent independent research ethics review.Provisions respecting its size, composition, terms of appointment and quorum are set out below.

Article 6.4 The REB shall consist of at least five members, including both men and women,of whom:

(a) at least two members have expertise in relevant research disciplines, fields andmethodologies covered by the REB;

(b) at least one member is knowledgeable in ethics;

(c) at least one member is knowledgeable in the relevant law (but that membershould not be the institution’s legal counsel or risk manager). This is mandatoryfor biomedical research and is advisable, but not mandatory, for other areas ofresearch; and

(d) at least one community member who has no affiliation with the institution.

It is advisable that each member be appointed to formally fulfil the requirementsof only one of the above categories.

To ensure the independence of REB decision making, institutional senior adminis-trators shall not serve on the REB.

Application This minimum requirement for REB membership brings to bear the necessary basicbackground, expertise and perspectives to allow informed independent reflectionand decision making on the ethics of research involving humans. At a minimum,the REB shall have members appointed in one capacity only for each of the mem-bership categories. Where the size of the REB exceeds the minimum requirements,additional members may fulfil more than one capacity. In any case, REB memberscan contribute to the review based on their experience, expertise or knowledge inmore than one of the categories above (Article 6.4[a] to [d]).

As an entity created and supported by the institution, an REB is encouraged to buildstrong relationships with its host institution and senior administration. The involve-ment of administrative staff dedicated to research ethics functions (e.g., the researchethics office administrator or director) may be relevant and appropriate to supportREB procedures. However, an institutional senior administrator (e.g., vice-president

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of research, director general or director of business development) should not serveon an REB, or directly or indirectly influence the REB decision-making process(see Articles 6.2 and 6.10). The mere presence of a non-voting institutional senioradministrator at REB meetings may be a source of real, potential or perceived con-flict of interest, and may therefore undermine the independence of the REB byunduly influencing REB deliberations and decisions (see Article 7.2).

The size of an REB may vary based on the diversity of disciplines, fields of researchand methodologies to be covered by the REB, as well as on the needs of the insti-tution. In appointing REB members, institutions should strive for appropriatediversity. Institutions may need to exceed the minimum REB membership require-ments in order to ensure adequate and thorough reviews, reasonable workload forREB members, or to respond to other local, provincial/territorial, or federal legalor regulatory requirements. For example, in the case of REB review of clinical tri-als, provincial/territorial or federal regulations may outline specific membershiprequirements in addition to the requirements set out in this Policy. Where REBsmainly review student research, they may consider adding a student REB member.Additional community representation should be commensurate with the size of theREB. Institutions are encouraged to establish a pool of substitute members (seebelow). Where research ethics administration staff have the requisite experience,expertise and knowledge comparable to what is expected of REB members, insti-tutions may appoint them (based on the written policies and procedures of theinstitution) to serve as non-voting members on the REB.

Relevant Expertise in Research Content and Methodology

At least two members should have the relevant knowledge and expertise to under-stand the content area and methodology of the proposed or ongoing research, andto assess the risks and potential benefits that may be associated with the research(Article 6.4[a]). For example, REBs reviewing oncology research, education ortopics involving Aboriginal peoples, or research using qualitative methodologies,should have members that are knowledgeable and competent to address those fieldsof research, disciplines and methodologies.

Knowledgeable in Ethics

Knowledge of ethics of research involving humans is key within the REB mem-bership as a whole. A member knowledgeable in ethics (Article 6.4[b]) needs tohave sufficient knowledge to guide an REB in identifying and addressing ethicsissues. A balance of ethics theory, practice and experience offers the most effectivepath to knowledge in ethics for REB membership. The kind and level of knowledgeor expertise needed on the REB will be commensurate with the types and com-plexities of research the REB reviews. For example, a member knowledgeable inethics serving on a social sciences and humanities REB may need to have differentcontextual and disciplinary knowledge in ethics than a member knowledgeable inethics serving on a biomedical REB.

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Knowledgeable in the Law

The role of the member knowledgeable in the law (Article 6.4[c]) is to alert REBsto legal issues and their implications (e.g., privacy issues), not to provide formallegal opinions or to serve as legal counsel for the REB. To avoid undermining theindependence and credibility of the REB, the institution’s legal counsel or risk man-ager should not be a member of the REB. In-house legal counsel might be seen toidentify too closely with the institution’s financial interest in having research goforward or, conversely, may be unduly concerned with protecting the institutionfrom potential liability. Any external legal counsel hired on a case-by-case basisby the institution should not serve as a member of that institution’s REBs whileworking for the institution.

An understanding of relevant legal issues and contexts is advisable for all REBs,although for non-biomedical research such insights may be sought from an ad hocadvisor whom the REB consults only for specific research projects. Where REBsreview research on complex topics that regularly requires advice on legal issues,they should appoint a member knowledgeable in the relevant law. In some in-stances, the legal issues that may be identified by the REB will necessitate furtherscrutiny and even formal legal advice by the legal counsel to the institution. Legalliability is a separate issue for institutions to handle through mechanisms other thanthe REB.

Community Member

The community member shall not be affiliated with the institution. The communitymember requirement (Article 6.4[d]) is essential to help broaden the perspectiveand value base of the REB, and thus advances dialogue with, and accountabilityto, relevant communities. In addition to a broad-based representation from the com-munity, it is highly desirable that institutions seek to appoint former participantson REBs. Their experience as participants provides the REB with a vital perspectiveand an important contribution to the research ethics review process. It is advisablethat members are not currently engaged in research or legal work as their principalactivities.

The role of community members on REBs during the ethics review process isunique and at arm’s length from the institution. Their primary role is to reflect theperspective of the participant. This is particularly important when participants arevulnerable and/or risks to participants are high.

To maintain effective community representation, the number of community mem-bers should be commensurate with the size of an REB and should increase as thesize of an REB increases. Institutions should provide training opportunities to com-munity members (see Article 6.7).

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Substitute Members

Institutions should consider the nomination of substitute REB members so thatREBs can continue to function when regular members are unable to attend due toillness or other unforeseen eventualities. The appointment of substitute membersshould not, however, alter the REB membership composition as set out in thisarticle. Substitute members should have the appropriate knowledge, expertise andtraining to contribute to the research ethics review process.

Ad Hoc Advisors

Article 6.5 The REB should have provisions for consulting ad hoc advisors in the event that itlacks the specific expertise or knowledge to review the ethical acceptability of aresearch proposal competently.

Application In the event that the REB is reviewing a project that requires particular communityor participant representation or specific disciplinary or methodological expertisenot available from its members, it should have provisions for consulting ad hoc ad-visors. Consultation with an ad hoc advisor shall not alter the composition andrepresentation of the REB as outlined in Article 6.4.

Ad hoc advisors are consulted for a specific research ethics review and for the du-ration of that review. Should this occur regularly, the membership of the REBshould be modified to ensure appropriate expertise on the REB. For example, incases where ethics review of research on topics related to Aboriginal peoples isregularly required, the REB membership should be modified to ensure that relevantand competent knowledge and expertise of Aboriginal cultures are captured withinits regular membership.

While ad hoc advisors may complement the REB through their experience, knowl-edge or expertise, their input is a form of consultation that may or may not beconsidered in the final decision of an REB. They are not REB members and, assuch, do not necessarily have the knowledge and experience gained from reviewingresearch proposals as members. Ad hoc advisors should not be counted in the quo-rum for an REB, nor be allowed to vote on REB decisions.

Terms of Appointment of REB Members

Article 6.6 In appointing REB members, institutions shall establish their terms to allow forcontinuity of the research ethics review process.

Application In appointing REB members, institutions should arrange the terms of members andtheir rotation to balance the need to maintain continuity with the need to ensure di-versity of opinion, and the opportunity to spread knowledge and experience gainedfrom REB membership throughout the institution and community. The REB mem-bership selection process should be fair and impartial. Institutions should havewritten policies that define the process of appointing REB members.

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Article 6.7 In appointing and renewing REB members, institutions should consider the quali-fications and expertise their REBs need. Institutions should provide REB memberswith necessary training opportunities to effectively review the ethical issues raisedby research proposals that fall within the mandate of their REB.

Application An REB should have adequate expertise, experience and training to understand theresearch disciplines, methodologies and approaches of the research that it considersfor research ethics review. Although an REB possesses the necessary expertiseglobally, each REB member brings specialized and complementary expertise andknowledge, or relevant experience to the ethics review of research involving hu-mans.

Institutions should ensure that all REB members receive appropriate education andtraining in ethics review of research involving humans, to enable them to fulfil theirduties. This includes providing training opportunities for all members in core prin-ciples and understanding of this Policy, basic ethics standards, applicableinstitutional policies, and legal or regulatory requirements. It includes an under-standing of the role and mandate of REBs and responsibilities of REB members.Training should be tailored to the types and complexities of the research the REBreviews. This training should be offered both upon the appointment of new mem-bers, and periodically throughout a member’s tenure.

Institutions should promote and recognize the contribution of REB members to theresearch ethics review process, as a valued and essential component of the researchenterprise.

REB Chair

Article 6.8 The REB Chair is responsible for ensuring that the REB review process conformsto the requirements of this Policy.

Application The role of the REB Chair is to provide overall leadership for the REB and to fa-cilitate the REB review process, based on institutional policies and procedures andthis Policy. The Chair should monitor the REB’s decisions for consistency and en-sure that these decisions are recorded accurately and communicated clearly toresearchers in writing as soon as possible by the Chair or his or her designate. In-stitutions shall provide the necessary resources and adequate administrative supportto enable the REB Chair to fulfill his or her responsibilities.

REB Quorum

Article 6.9 Institutions shall establish quorum rules for REBs that meet the minimum require-ments of membership representation outlined in Article 6.4. When there is less thanfull attendance, decisions requiring full review should be adopted only when the

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members in attendance at that meeting have the specific expertise, relevant com-petence and knowledge necessary to provide an adequate research ethics reviewof the proposals under consideration.

Application Institutions shall establish REB quorum rules subject to the range of competenceand knowledge required by this Policy to ensure the soundness and integrity of theresearch ethics review process. To maintain quorum when REB members aregeographically dispersed or in unexpected circumstances (e.g., emergencies), inputfrom member(s) is allowed by other means, such as the use of technology (seeArticle 6.10).

Ad hoc advisors, observers, research ethics administration staff and others attendingREB meetings should not be counted in the quorum for an REB. Nor should theybe allowed to vote on REB decisions (see Article 6.5). Decisions without a quorumare not valid or binding.

REB Meetings and Attendance

Article 6.10 REBs shall have regular meetings to discharge their responsibilities, and shallnormally meet face to face to review proposed research that is not assigned todelegated review.

Application Face-to-face meetings are essential for adequate discussion of, and effective REBdecision making on, research proposals, and for the collective education of theREB. The face-to-face medium provides interactive dynamics that tend to heightenthe quality and effectiveness of communications and decisions.

Planning regular meetings is essential to fulfilling REB responsibilities. Where amember is frequently absent, the REB should have some mechanism for reviewingwhether that member should continue to serve on the REB. Unexpected circum-stances such as emergencies may prevent individual member(s) from attending theREB meeting. In these exceptional cases, input from member(s) by the use of tech-nology (e.g., phone or video link) would be acceptable.

Videoconferencing, teleconferencing or use of other technologies may be regardedas necessary for meetings when REB members are geographically dispersed andthere is no other way of holding an effective REB meeting, or when exceptional orexigent circumstances significantly disrupt or limit the feasibility of face-to-faceREB meetings (e.g., during a public emergency). All efforts should be made toensure that technical difficulties do not prevent the maintenance of quorumthroughout the meeting. Use of such technologies requires the Chair to ensure activeparticipation of members not physically present. Institutions should considerdeveloping written procedures for the occasional use of videoconferences or othertechnologies by an REB.

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In the design phase of their research prior to the formal ethics review process, re-searchers may consult informally with REBs. Such dialogue can establish the stageat which REB review and approval would be required, or facilitate the review. Suchinformal meetings cannot, however, substitute for the formal review process. Aschedule of REB meetings should be communicated to researchers for the planningof ethics review of their research.

On occasion REBs may need to consult other resources within or outside the insti-tution for advice, and may invite experts to attend their meetings. REBs shouldconsider whether the institutional functions of other individuals attending theirmeetings could exercise undue influence, or provide elements of power imbalancesor coercion that would affect REB review, deliberations and decisions (see Articles6.4 and 6.5 and Chapter 7).

REBs should establish a process for the basis of arriving at decisions requiring fullREB review. For example, they may arrive at decisions by consensus, and wherethis is not possible resort to a vote. REBs should hold general meetings, retreatsand workshops to enhance educational opportunities that may benefit the overalloperation of the REB, discuss any general issues arising out of the REB’s activitiesor revise relevant policies.

B. Procedures for REB Review

Initial Research Ethics Review

Article 6.11 Researchers shall submit their research proposals, including proposals for pilotstudies, for REB review and approval of its ethical acceptability prior to the startof recruitment of participants, access to data, or collection of human biological ma-terials. REB review is not required for the initial exploratory phase, which mayinvolve contact with individuals or communities intended to establish research part-nerships or to inform the design of a research proposal.

Application REB review and approval of the ethical acceptability of research is required beforerecruitment, formal data collection involving participants, access to data, or col-lection of human biological materials. Similarly, as an integral component of theirresearch design, researchers may undertake pilot studies involving participants. Forthe conduct of pilot studies, researchers shall seek consent from prospective par-ticipants and obtain REB approval before recruitment or the formal data collectioninvolving participants, or access to data, or collection of human biological materialsin accordance with the provisions in this Policy.

Researchers shall submit sufficient details to enable the REB to make an informedreview of the ethical acceptability of the research.

Some types of research using quantitative, qualitative research, or a combinationof these methods, as well as collaborative or community-based research (see

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Chapters 9 and 10) may entail prior contact and dialogue with individuals orcommunities as a normal and integral component to establish researchcollaborations or partnerships prior to the actual design of the research. Otherresearch may, at their initial stages, not involve humans, but require engaging theresearch team, setting up equipment and other preparatory stages. These activitiesmay precede REB review.

Determining the Level of Research Ethics Review

Article 6.12 In keeping with a proportionate approach to research ethics review, the selectionof the level of REB review shall be determined by the level of foreseeable risks toparticipants: the lower the level of risk, the lower the level of scrutiny (delegatedreview); the higher the level of risk, the higher the level of scrutiny (full boardreview).

Application REBs shall assess the level of risk that the research under review poses toparticipants to determine the appropriate level of research ethics review (delegatedor full REB review). (For a full discussion of the proportionate approach to researchethics review, see Chapter 1, Section C, and Article 2.9). This applies to both initialresearch ethics review (see Article 6.11) and continuing research ethics review (seeArticle 6.14).

With the support of their institutions, REBs may develop their own mechanismsunder which delegation of the conduct of research ethics review, decision makingand the associated reporting processes will occur. Those mechanisms andprocedures should be made public. It is the REB, based on its establishedprocedures and through its Chair, that decides on the level of review for eachresearch proposal.

Two levels of research ethics review may apply:

1) Full REB review

Research ethics review by the full REB should be the default requirement forresearch involving humans.

2) Delegated REB review of minimal risk research

The REB delegates research ethics review to an individual or individuals. Del-egates shall be selected from among the REB membership with the exceptionof the ethics review of student course-based research. This can be delegated tothe department, faculty or equivalent level as indicated below.

Where it is determined that the research is of minimal risk (defined in Chapter 2 ofthis Policy), an REB may authorize a delegated research ethics review in accor-dance with its institutional policies and written procedures. Delegated reviewer(s)shall be selected from the REB membership: the REB Chair or another member

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(see Article 6.4 on the appointment of research ethics administration staff to theREB as non-voting members). Research ethics review may also be undertaken bynon-REB members for student course-based research as outlined below. Delegatedreviewers who are non-members or non-voting members of the REB must haveexperience, expertise and knowledge comparable to what is expected of an REBmember.

The REB may decide that its Chair or other REB member(s) may review andapprove categories of research that are confidently expected to involve minimalrisk. Delegated reviewers may call on other reviewers within the REB or referprojects back to the full REB if they determine that full board review is required.Where delegates consider a negative decision (i.e., one that would refuse ethicsapproval), this decision shall be referred to the full REB for review andendorsement before communicating the decision to the researcher.

An institution may decide that ethics review of course-based research activitiesintended solely for pedagogical purposes can be delegated to non-REB membersat the institution’s department, faculty or equivalent level. Such pedagogicalactivities are normally required of students (at all levels) with the objective ofproviding them with exposure to research methods in their field of study (e.g.,interviewing techniques). If these activities are used for the purposes of research(e.g., as part of a researcher’s own research program), they should be reviewed bythe regular institutional REB procedures. Theses or equivalent research projectsinvolving human participants typically meet this Policy’s definition of research(see Application of Article 2.1), and should be reviewed by the REB following aproportionate approach (see Article 6.12). The REB should establish writtenprocedures and set out criteria for determining which categories of researchproposal may be eligible for this type of review, and specify who is responsible forimplementing and overseeing the approval mechanisms.

In delegating research ethics review, the REB should carefully select delegatedreviewer(s) and ensure that all delegated reviewers who are not members of theREB have the appropriate experience, expertise, training and resources required toreview the ethical acceptability of all aspects of the proposal in accordance with thisPolicy. In the selection of delegated reviewers, special attention should be given tothe assessment of real, potential or perceived conflicts of interest (see Article 7.3).

Examples of categories that may be delegated for research ethics review include:

• research that is confidently expected to involve minimal risk;

• minimal-risk changes to approved research;

• annual renewals of approved minimal risk research;

• annual renewals of more than minimal risk research where the remaining

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research-attributable risk is minimal e.g., the research will no longer involve new interventions to current participants and no additional participants will be enrolled in the study;

• annual renewals of more than minimal risk research in which there has been:

- no significant changes to the research,

- no increase in risk to (or other ethical implications for) the participants since the most recent review by the full REB, and

- the REB Chair has determined that the delegated review process is appropriate.

Note that other applicable guidelines or policies (such as ICH-GCP) may requirea full REB review of the annual renewal for specific types of research.

An REB that implements a delegated review process shall require that the actionsand decisions of the delegated reviewer(s) be well documented and formally re-ported to the full REB, in a timely and appropriate manner. Where the delegatedreview is conducted by non-voting members or non-members of the REB, this for-mal report shall be made through the Chair. This will permit the REB to maintainoversight over the decisions made on its behalf so as to protect the interests of par-ticipants. Accountability requires that, regardless of the review strategy, the REBcontinues to be responsible for the ethics of all research involving humans withinits jurisdiction.

Decision Making

Article 6.13 REBs shall function impartially, provide a fair hearing to the researchers involved,and provide reasoned and appropriately documented opinions and decisions. REBsshould make their decisions on the ethical acceptability of research in an efficientand timely manner, and shall communicate all approvals and refusals to researchersin writing, in print or by electronic means, in accordance with their procedures.

Application The REB shall accommodate reasonable requests from researchers to participatein discussions about their proposals. The REB may also invite researchers to attendan REB meeting to provide further information about their proposal. In either case,the researchers shall not be present when the REB is making its decision. When anREB is considering a negative decision, it shall provide the researcher with all thereasons for doing so and give the researcher an opportunity to reply before makinga final decision (see Article 6.18).

In the event that a minority within the REB membership considers a researchproject unethical, even though it is acceptable to a majority of members, an effortshould be made to reach consensus. Consultation with the researcher, externaladvice or further reflection by the REB may be helpful. If disagreement persists, adecision should be made in accordance with the process agreed upon, and

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documented by the REB. In such instances, the minority position may becommunicated to the researcher.

Participation by the researcher in REB discussions is often very helpful to bothREBs and researchers. It may result in a deferral of the REB’s decision until theresearcher has considered the discussions and possibly modified the proposal. Suchdiscussions are an essential part of the educational role of the REB.

Continuing Research Ethics Review

Article 6.14 The REB shall make the final determination as to the nature and frequency of con-tinuing research ethics review in accordance with a proportionate approach toresearch ethics review. At minimum, continuing research ethics review shall consistof an annual status report (for multi-year research projects), and an end-of-studyreport (projects lasting less than one year).

Application Research is subject to continuing research ethics review from the date of initialREB approval throughout the life of the project (see Article 2.8). At the time of theinitial review, the REB has the authority to determine the term of approval, and thelevel at which continuing ethics review occurs in accordance with a proportionateapproach to research ethics review. As with initial review, continuing ethics reviewcould be full board review or delegated review based on the level of risk of the re-search (see Article 6.12). The level of research ethics review may be adjusted overthe life of the project based on the level of risk.

For research projects lasting longer than one year, researchers shall submit, at min-imum, an annual report with sufficient details to enable the REB to make aninformed judgment about the continued ethical acceptability of the research. Forresearch lasting less than one year, an end-of-study report may suffice.

Institutional ethics policies should include provisions that assist REBs, researchersand institutions to determine when continuing research ethics review is no longerrequired. Such provisions should consider different types of research designs (e.g.,short-term project, longitudinal research, research with reporting back require-ments). They should also consider issues such as the extent of any remaining riskto participants, the nature of plans (if any) for future interaction with participants;the status of any commitments or agreements made to participants, for example,with respect to reporting findings; and/or the relative likelihood of future unantic-ipated events, material incidental findings, or new information.

For some types of research (e.g., qualitative research or longitudinal research),there may be some difficulty in establishing start or end dates. In these cases, theREB should work with researchers to determine a reasonable timeline for contin-uing ethics review, and for determining the completion date dependent on thediscipline and method of research. The reporting schedule for continuing ethics re-view may be adjusted throughout the life of the project. This would be necessary,

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for example, if the risk level of the research increases as a result of the addition ofnew procedures, or is re-assessed in light of changes to the approved research (seeArticles 6.15 and 6.16).

Research that involves minimal or no risk to participants should be held to the min-imum requirements for continuing ethics review, that is, an annual report.Consistent with a proportionate approach, an REB has the option of requestingmore frequent and/or more substantive reports if necessary. Research that posesgreater-than-minimal risk may require more extensive continuing ethics review.This may include more frequent reporting to the REB, monitoring and review ofthe consent process, review of participant records, and site visits. Other reportingmechanisms for continuing ethics review may be required by funders, sponsors orregulators.

Continuing research ethics review should be understood as a collective responsi-bility, to be carried out with a common interest in maintaining the highest ethicalstandards:

• Institutions have a responsibility to provide necessary resources to REBs to assist them in fulfilling their continuing ethics review responsibilities;

• REBs make the final decision about the nature and frequency of continuingethics review;

• Researchers’ responsibilities include monitoring their research to ensure that it is conducted in an ethical manner, reporting unanticipated issues (see Article 6.15) or changes to the research (see Article 6.16), supervisingall team members in the application of the research procedures, and ensuring that they are properly qualified and versed in the conduct of ethical research.

Reports of Unanticipated Issues

Article 6.15 Researchers shall report to the REB any unanticipated issue or event that mayincrease the level of risk to participants, or has other ethical implications that mayaffect participants’ welfare.

Application Over the course of the implementation of the approved research project, issues mayarise that the researcher did not anticipate when originally submitting the researchfor ethics review. Unanticipated issues include unexpected reactions by participantsto a research intervention (e.g., unintended stimulation of traumatic memories, un-foreseen side-effects of a medication or natural health product), as well asunavoidable single incidents (e.g., a translator not available for a day, or a failureto follow correct research procedure for one participant on one occasion). Theymay be minor or serious in magnitude, with short- or long-term implications.

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Any unanticipated issue that increases the level of risk to participants or has otherethical implications should be reported to the REB without delay. Changes that arenecessary to eliminate an immediate risk(s) to the participants may be implementedas needed, but must be reported to the REB at the earliest opportunity. For clinicaltrials, reporting requirements for safety data or unanticipated issues are alsoaddressed in Chapter 11 (Articles 11.7 and 11.8). If the incident or issue hasimmediate implications for the safety of participants, the REB may withdraw ethicsapproval, which would require that the research be halted or modified until thematter can be addressed (see Article 6.3 and Articles 11.8 and 11.9). It may requiresubmission of a revised research proposal for REB review.

Minor deviations from the research (e.g., a slight increase or decrease of testingtime, a wording adjustment on a question) should not require immediate reportingto the REB, but may be summarized in annual status reports (see Article 6.14). Insome types of qualitative research, for example, emergent design (see Article 10.5),the research design evolves over time, so adjustments to the research are to beexpected and need not be reported to the REB, unless they alter the level of risk orhave other ethical implications for participants (see Article 6.16).

The report to the REB should include a description of the unanticipated issue orincident, including details of how the researcher(s) dealt with the situation. Reportsmay be submitted by researchers, or in some cases by data safety monitoring boards(see Article 11.7 and 11.8). The point in reporting is to enable the REB and theresearcher to better protect participants. Depending on the nature of the issue, andin consultation with researchers, REBs may require that researchers adjust theirprocedures to prevent its recurrence during the research project.

Requests for Changes to Approved Research

Article 6.16 Researchers shall submit to their REBs in a timely manner requests for substantivechanges to their originally approved research. REBs shall decide on the ethical ac-ceptability of those changes to the research in accordance with a proportionateapproach to research ethics review.

Application In general, it is not the size of the change that dictates the ethics review process,but rather the ethical implications and risk associated with the proposed change.In case of doubt on the potential impact of the change to approved research on thelevel of risk to participants, researchers should consult with their REBs. Changesthat substantially alter the nature of the approved research may be assessed as anew research project and require a new REB review.

In the conduct of their approved research, researchers should be aware of therequirement to report to their REB, in a timely manner, proposed changes fromapproved research that affect participants at any stage of the process including, butnot limited to, changes to the consent form, changes to the tasks or interventions

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involved in the research, or changes to measures to protect privacy andconfidentiality. Any substantive change to the research should not be implementedwithout documented approval by the REB, except when necessary to eliminate animmediate risk(s) to the participants.

Requests for changes to approved research may receive delegated or full REBreview depending on the level of risk to participants that the changes represent.REB evaluation of these requests can result in a change to the assessed risk of theresearch and a corresponding change in the level of continuing ethics review.

REBs should give special attention to circumstances that may necessitate changein long-term research such as new knowledge, equipment or instruments, or newor revised applicable policies and laws that may develop over the lifetime of aresearch project.

Record Keeping of REB Documents

Article 6.17 REBs shall prepare and maintain comprehensive records, including all documen-tation related to the projects submitted to the REB for review, attendance at all REBmeetings, and accurate minutes reflecting REB decisions. Where the REB deniesethics approval for a research proposal, the minutes shall include the reasons forthis decision.

Application REBs need to act, and to be seen to be acting, fairly and reasonably. Institutionsshall provide REBs with the necessary resources to enable them to maintain com-plete study files, including the original research proposal, as well as annual andend-of-study reports. When deciding the retention period of their files, REBs shouldbe guided by their institutional record-keeping policies and other relevant legal orregulatory requirements. Files, minutes and other relevant documentation shall beaccessible to authorized representatives of the institution, researchers, sponsors andfunders when necessary to assist internal and external audits, or research monitor-ing, and to facilitate reconsideration or appeals.

The minutes of REB meetings shall clearly document the REB’s decisions, anydissents and the reasons for them. REB decisions should be supported by clearreferences (e.g., date of decision, title of project), documentary basis for decision(i.e., documents or progress reports received and reviewed), the plan for continuingethics review and timelines, reasons for decisions, and any conditions or limitationsattached to the approval. Providing reasons for REB decisions is optional whenethics approval is granted.

REBs should have written procedures for its management of record keeping andother submitted reports. REBs shall maintain reports and decisions on unanticipatedissues or changes to approved research, including details of how the researcherdealt with or is proposing to deal with the situation and the REB’s response ordecision (see Articles 6.15 and 6.16).

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The research ethics administration should also maintain general records related toREB membership and qualifications of members (e.g., copies of curriculum vitae,participation in relevant research ethics training).

C. Reconsideration and Appeals

Where researchers do not receive ethics approval, or receive approval conditional on revisionsthat they find compromise the feasibility or integrity of the proposed research, they are entitled toreconsideration by the REB. If that is not successful, they may appeal using the established appealmechanism in accordance with the institution’s procedures.

Reconsideration of REB Decisions

Article 6.18 Researchers have the right to request, and REBs have an obligation to provide,prompt reconsideration of decisions affecting a research project.

Application Researchers and REBs should make every effort to resolve disagreements they mayhave through deliberation, consultation or advice. If a disagreement between theresearcher and the REB cannot be resolved through reconsideration, the researchershall have the option of appealing the REB decisions through the established appealmechanism (see Article 6.19). REBs should establish timelines to promptly conductreconsiderations and issue their decision.

The onus is on researchers to justify the grounds on which they request reconsid-eration by the REB and to indicate any alleged breaches to the established researchethics review process, or any elements of the REB decision that are not supportedby this Policy.

Appeal of REB Decisions

Article 6.19 Institutions shall have an established mechanism and a procedure in place forpromptly handling appeals from researchers when, after reconsideration, the REBhas refused ethics approval of the research.

Application In cases when researchers and REBs cannot reach agreement through reconsider-ation, the institution shall provide access to an established appeal process for thereview of an REB decision. The researcher and the REB must have fully exhaustedthe reconsideration process, and the REB must have issued a final decision beforethe researcher initiates an appeal.

Based on its written institutional policies, the same authority that established theREB shall establish or appoint an appeal committee that reflects a range of expertiseand knowledge similar to that of the REB, and that meets the procedural require-ments of this Policy. An appeal committee may be an ad hoc or a permanentcommittee. Members of the REB whose decision is under appeal shall not serveon that appeal committee.

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It should be stressed that the appeal process is not a substitute for REBs andresearchers working closely together to ensure high-quality ethical research, nor isit a forum to merely seek a second opinion.

Institutions may wish to explore regional cooperation or alliances, including thesharing of appeal boards. If two institutions decide to use each other’s REB as anappeal board, a formal letter of agreement between institutions is required (seeChapter 8).

It is not the role of the three federal research Agencies that are responsible for thisPolicy to consider any appeals of REB decisions.

Article 6.20 The appeal committee shall have the authority to review negative decisions madeby an REB. In so doing, it may approve, reject or request modifications to theresearch proposal. Its decision on behalf of the institution shall be final.

Application Researchers have the right to request an appeal of an REB decision. An appeal canbe launched for procedural or substantive reasons. The onus is on the researchersto justify the grounds on which they request an appeal and to indicate any breachesto the research ethics review process or any elements of the REB decision that arenot supported by this Policy.

The appeal committee shall function impartially, provide a fair hearing to thoseinvolved, and provide reasoned and appropriately documented opinions anddecisions. Both the researcher and a representative of the REB shall be granted theopportunity to address the appeal committee, but neither shall be present when theappeal committee deliberates and makes a decision. Appeal committee decisionson behalf of the institution shall be final, and should be communicated in writing(in print or by electronic means) to researchers and to the REB whose decision wasappealed. Recourse to judicial review may be available to the researcher.

D. Research Ethics Review during Publicly Declared Emergencies

This section addresses research ethics review within the context of the official declaration of publicemergencies. For the purposes of this Policy, a publicly declared emergency is an emergencysituation that, due to the extraordinary risks it presents, has been proclaimed as such by anauthorized public official (in accordance with legislation and/or public policy).

Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, andrequire urgent or quick responses to minimize devastation. Examples include hurricanes and othernatural disasters, large communicable disease outbreaks, catastrophic civil disorders, bio-hazardousreleases, environmental disasters, and humanitarian emergencies. They tend to be time-limited.They may severely disrupt or may destroy normal functioning of institutions and communities, aswell as individual lives. Once an emergency has been designated a publicly declared emergency,

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authorities may exercise special responsibilities and powers to deal with the situation, and theexercise of those responsibilities may temporarily modify normal procedures or practices. Thissection therefore applies to narrow, limited and exceptional circumstances.

There is a growing awareness of the need for institutional planning to respond to publicly declaredemergencies, and the associated potential challenges for research ethics review. Given theextraordinary circumstances that participants are potentially subjected to in publicly declaredemergencies, special attention and effort should be given to upholding the core principles ofRespect for Persons, Concern for Welfare, and Justice when reviewing the ethics of research to beconducted in emergencies. It should be noted that the following articles and the requirement forconsent will not apply to public health activities undertaken by federal, provincial and territorialpublic health officials operating under statutory powers during publicly declared health emergencies.

Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies

Article 6.21 In collaboration with their researchers, institutions and their REBs should developpreparedness plans for emergency research ethics review. Research ethics reviewduring publicly declared emergencies may follow modified procedures and prac-tices.

Application Preparedness plans should outline policies and procedures for addressing researchethics review during public health outbreaks, natural disasters and other publiclydeclared emergencies. Research ethics policies and procedures, and their imple-mentation, should adhere rigorously to a rule of reasonable, fair, and principleddesign and use during publicly declared emergencies.

Through their emergency preparedness plans, institutions, researchers and theirREBs need to anticipate the pressures, time constraints, priorities and logisticalchallenges that may arise to ensure quality, timely, proportionate and appropriateresearch ethics review. The plan and its policies should proactively address basicoperational questions. Examples include, but are not limited to, how emergenciesmay affect research and research ethics review in institutions; how REBs conductbusiness or meetings; what research needs should be planned in advance of, or ad-dressed after, an emergency; what research, if any, needs to be done during anemergency; what qualifies as time-sensitive or “essential” research; what proce-dures govern the research ethics review process in emergency circumstances; andwhat evaluation methods need to be developed for post-response evaluations to in-form any revisions to the institution’s emergency procedures. It is important to pilottest the emergency procedures and plans in advance.

Policies should try to anticipate the extraordinary circumstances or demandsoccasioned by emergencies and set priorities among them. For example, REBsshould try to work collaboratively with researchers who would likely be involvedin emergency research (e.g., relevant biomedical, environmental and social scienceresearchers), and determine what special consent provisions may be made (seeChapter 3). Institutions might consider the use of an instrument to identify and

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triage the kinds of research that should be designed before, undertaken during orconducted after officially declared public emergencies. Likewise, a plan to helpprioritize REB reviews during emergencies should take into account the following:

• what research is “essential” research during the emergency;

• the initial ethics review process of new research projects arising from the emergency (e.g., research involving interviews with first responders and victims to understand human response during a disaster, such as a tornado or earthquake);

• continuing ethics review of research undertaken prior to the occurrence of the emergency; and

• the ethics review process for changes to approved research, because new information may become available and require action very rapidly during emergencies (see Articles 6.15 and 6.16).

REB procedures may warrant reasonable adjustments to address the timing, locale,expertise, form and scope of research ethics review, and the holding of REB meet-ings during emergency situations (see Article 6.10). Special attention could be givento REB procedures to review and approve research (e.g., full or delegated researchethics reviews, quorum rules, or special agreements with other institutions), whileconsidering the impact of the emergency on participants, researchers, REB mem-bers, institutional staff, and others. It is also important to coordinate research effortsand research ethics review processes within and across institutions. REB membersmay become unavailable (e.g., due to illness, relocation, or quarantine by publicauthorities). Institutions and REBs should explore the nomination of substitute REBmembers and consultation with ad hoc advisors with relevant expertise (see Articles6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB re-views (see Article 8.1), and revisit how scholarly review (see Article 2.7) wouldbe applied in emergency situations.

Research ethics review should be commensurate with the necessities occasionedby the emergency because of the critical interplay between public urgencies,essential research and a continuing commitment to the core principles even in theface of acute public necessity. Indeed, research ethics review during publiclydeclared emergencies is even more important than under normal circumstances,and may require even greater care, since everyone (participants, researchers andREB members themselves) may be rendered more vulnerable by the nature of theemergency.

Research Ethics Review Policy and Procedures during Publicly Declared Emergencies

Article 6.22 Research ethics policies and procedures for emergencies take effect once an emer-gency has been publicly declared. They should cease to apply as soon as is feasibleafter the end of the publicly declared emergency.

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Application Because emergencies present extraordinary public risks that warrant special re-sponses, legislation or public policies usually require that they be officiallyproclaimed or declared. Research ethics review procedures that have been estab-lished for use during publicly declared emergencies should be applied only afteran authorized public official declares a public emergency. These procedures there-fore apply to very narrow, limited and exceptional circumstances. Institutions andREBs must endeavour to return to normal operating procedures as soon as possibleafter public officials have declared that the emergency is over.

Respecting Core Principles: Limiting Exceptions

Article 6.23 REBs should give special care to requests for exceptions to the principles and pro-cedures outlined in this Policy during publicly declared emergencies.

Application Especially during times of emergency, researchers, REBs and institutions need tobe vigilant and exercise due diligence in respecting ethical principles, proceduresand the law in effect during the emergency to preserve the values, purpose and pro-tection that the principles of this Policy advance.

To guide fair and reasonable implementation of these principles in emergencycircumstances, any exception to, or infringement of, ethics principles and REBprocedures must be demonstrably justified by those urging the exception orinfringement.

Where exceptions to or infringements of ethics principles and REB procedures arejustified, they should be narrowly tailored to address the necessities occasioned bythe publicly declared emergency, such that they rely on the most restrictive or leastintrusive means necessary to achieve the Policy goal: the promotion and guidanceof ethical conduct in research. This approach – consistent with internationalbioethics and human rights norms – maximizes respect for ethical principles andhelps to ensure that exceptions and the means to implement them are not undulybroad, overreaching or unjustifiably invasive.

Recognizing and respecting the principle of Justice means that research ethics re-view policies and procedures for publicly declared emergencies shall be used in amanner that is not discriminatory or arbitrary. The commitment to justice advancesa fair and balanced distribution of risks and potential benefits even in the face ofpublic emergencies.

REBs and researchers should be aware that individuals, prospective participants,researchers, and institutions may not normally be considered vulnerable, but maybecome so by the very nature of public emergencies. Those already vulnerable maybecome acutely so (see Article 4.7). The increased public risks and devastation thatcause public emergencies to be declared can threaten autonomy and physical, emo-tional, institutional and social welfare or safety. They also bring inherent tensions

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and pressures that may impact deliberative decision making. Taking all of this intoconsideration, REBs and researchers should ensure that the risks and potential ben-efits posed by any proposed research are appropriately evaluated, includingprovisions for greater-than-normal attention to risk, where applicable.

Endnote

1 Agreement on the Administration of Agency Grants and Awards by Research Institutions.

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Chapter 7CONFLICTS OF INTEREST

Introduction

This chapter addresses ethical issues that can arise when research activities and other activitiesconflict. A conflict of interest may arise when activities or situations place an individual or insti-tution in a real, potential or perceived conflict between the duties or responsibilities related toresearch, and personal, institutional or other interests.1 These interests include, but are not limitedto, business, commercial or financial interests pertaining to the institution and/or the individual,their family members, friends, or their former, current or prospective professional associates.

Conflicts of interest must be assessed when conducting research as they may jeopardize the in-tegrity of the research and the protection offered to participants. Conflicts that create dividedloyalties may distract researchers, research ethics boards (REBs), and institutions from concernfor the welfare of participants and are contrary to the core principles on which this Policy is based.Failure to disclose and manage conflicts may impede the informed and autonomous choices of in-dividuals to participate in research. Prospective participants need to know about real, potential orperceived conflicts of interest in order to make an informed decision about whether or not to par-ticipate (see Article 3.2[e]). Conflicts of interest may also undermine the respect for participantsthat is fundamental to the principle of Justice.

It is preferable to avoid or prevent being in a position of conflict of interest, if possible. When itis not possible to avoid a conflict of interest, then it shall be disclosed to the appropriate peopleand steps taken to minimize or manage the conflict. Researchers, their institutions and REBs shouldidentify and address conflicts of interest – real, potential or perceived – to discharge professionaland institutional obligations, maintain public confidence and trust, and ensure accountability. Insome cases, the conflict cannot be managed and the institutions, the researcher or the REB membermay need to abandon one of the interests in conflict. When necessary, researchers may have tomanage a conflict of interest either by disclosing it to participants or by removing themselves fromthe research.

A. Key Concepts

Institutional Conflict of InterestInstitutions involved in research hold trust relationships with participants, research sponsors, re-searchers and society. These institutions may have financial or reputational interests including,but not limited to, the provision of education and the promotion of research that conflict with theinstitution’s obligations to protect and respect human dignity as characterized by the core principlesof this Policy. For example, institutions may experience pressures to attract particular research

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funding or certain types of research activities that are self-sustaining, which may compromise theirindependence and public trust. Institutions have an obligation to ensure that the ethical conduct ofresearch is not compromised by real, potential or perceived conflicts of interest.

An institutional conflict of interest involves a conflict between at least two substantial institutionalobligations that cannot be adequately fulfilled without compromising one or both obligations.Conflicts may occur when pursuing particular goals, for instance, the pursuit of two different“goods,” such as an effort to obtain general infrastructure funding from a donor that conflicts withan effort to promote research that the donor does not wish to support.

Institutional conflicts of interest may compromise duties of loyalty and lead to biased judgments.Conflicts may also undermine public trust in the ability of the institution to carry out its missions,operations and ethical responsibilities in research.

Institutions may be in conflict of interest, for example, when they (a) sponsor a research project;(b) manage the intellectual property that forms the basis of a research project or stand to benefitfrom intellectual property resulting from the research; (c) hold equity in companies and/or receivemajor donations; or (d) have conflicting roles carried out by one institutional official (e.g., a vice-president who is responsible for the promotion of research activity and funding and also foroversight of research).

Acting in a professional role within the institution, individuals (e.g., institution president, vice-president, dean of a faculty or department head) are in a conflict of interest when they are subjectto competing incentives or functions. These may significantly interfere with the impartial exerciseof duties, including legal and ethical obligations within the institutional structure. The conflictmay be chronic, relating to recurring situations resulting from the institutional structure, or it maybe triggered by a unique situation that is not likely to recur.

REB Member Conflict of Interest

The REB, as an entity, or in the persons of the members who make up the board, also hold trustrelationships with participants, research sponsors, researchers and society. REB members mustalso be aware of their own potential for real or perceived conflicts of interest.

For example, REB members are in a conflict of interest when their own research projects are underreview by their REB, when they are a co-investigator, or when they are in a supervisory or men-toring relationship with a graduate student applicant. REB members may also be in a conflict ofinterest situation when they have interpersonal or financial relationships with the researchers, orpersonal or financial interests in a company, labour union or not-for-profit organization that maybe the sponsor of the research project, or that may be substantially affected by the research.

Conflicts of interest based on collaborations or disputes with colleagues, students or others maybe ongoing or of limited duration. REBs have an obligation to ensure that the fairness and trans-parency of research ethics review is not compromised by real, potential or perceived conflicts ofinterest.

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Researcher Conflict of InterestResearchers and research students hold trust relationships, either directly or indirectly, with par-ticipants, research sponsors, institutions, their professional bodies and society. These trustrelationships can be put at risk by conflicts of interest that may compromise independence, objec-tivity or ethical duties of loyalty. Although the potential for such conflicts has always existed,pressures on researchers (e.g., to delay or withhold dissemination of research outcomes or to useinappropriate recruitment strategies) heighten concerns that conflicts of interest may affect ethicalbehaviour.

Researchers’ conflicts of interest may arise from interpersonal relationships (e.g., family or com-munity relationships), financial partnerships, other economic interests (e.g., spin-off companiesin which researchers have stakes or private contract research outside of the academic realm), ac-ademic interests or any other incentives that may compromise integrity or respect for the coreprinciples of this Policy. Conflicts may arise from an individual’s involvement in dual and multipleroles within or outside an institution. While it may not be possible to eliminate all conflicts of in-terest, researchers are expected to identify, minimize or otherwise manage their individual conflictsin a manner that is satisfactory to the REB.

B. Institutions and Conflicts of Interest

Article 7.1 Institutions shall develop and implement conflict of interest policies includingprocedures to identify, eliminate, minimize or otherwise manage conflicts ofinterest that may affect research. All parties (e.g., researchers, administrators, REBmembers) should act in a transparent manner in identifying and addressing conflictsof interest. Institutions should make their written conflict of interest policies andprocedures publicly available to all members of the research enterprise, includingparticipants, REBs, researchers, administrators and research sponsors.

Application To meet obligations to protect participants, institutional policies should address theroles, responsibilities and process for identifying, eliminating, minimizing or oth-erwise managing institutional conflicts of interest relevant to research, includingdisclosure to REBs. Management of conflicts of interest includes, but is not limitedto, prevention, evaluation, disclosure and the application of appropriate remediesas defined by the institution.

When developing institutional policies and procedures on conflicts of interest, in-stitutions should clarify roles and the distribution of responsibilities, and clarifyassociated potential for conflicts. This clarity should reduce or eliminate the pos-sibility for confusion of roles that may ultimately lead to conflicting obligations.Ideally, institutional policies will organize roles, responsibilities, reporting linesand accountabilities to eliminate, minimize or otherwise manage conflicts of inter-est (see Articles 6.1, 6.2 and 7.2).

Measures to manage conflicts of interest should reflect the inherent threat of con-flicts of interest to participants, as well as to the scientific and scholarly integrity

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and credibility of research. These measures should also be commensurate with therisks. Institutions should consider the following measures to address conflicts ofinterest at the institutional level that are germane to research involving humans:

• Create central institutional mechanisms, such as a competent institutional au-thority, a conflict of interest committee, or other delegated bodies within theinstitution to help identify, eliminate, minimize or otherwise manage conflictsof interest.

• Refine or redesign roles, responsibilities, and reporting lines to eliminate, min-imize or manage the potential for conflict of interest.

• Prevent or minimize conflict of interest in institutional design and structuringwhen creating new roles, responsibilities or relationships.

• Apply barriers to insulate potentially conflicting roles and responsibilities.

• Require that individuals involved in the conduct of research withdraw from, ornot participate in, roles or functions unduly compromised or disabled by anyreal, potential or perceived conflict.

Conflict of interest policies and procedures should be developed in a transparentmanner. The goal of these policies is to eliminate conflict of interest where possible,or alternatively, to identify and disclose real, potential or perceived institutionalconflicts of interest, to make them transparent and open to scrutiny, and to providemechanisms to minimize or otherwise manage them.

Article 7.2 Institutions should ensure that real, potential or perceived institutional conflicts ofinterest that may affect research are reported to the REB through established con-flict of interest mechanisms. The REB shall consider whether the institutionalconflict of interest should be disclosed to prospective participants as part of theconsent process.

Application Any member of an institution, a senior administrator, researcher, REB member orany other individual who is aware of potential sources of institutional conflicts ofinterest that may affect research should refer to the institutional policy for the ap-propriate steps to inform the REB. Institutional policies shall address whendisclosure of conflicts of interest to the REB is required and how these conflictsshould be evaluated and managed.

Likewise, when a real, potential or perceived institutional conflict of interest is dis-closed and brought to its attention, the REB may be guided by the prescribedinstitutional mechanisms for managing the conflict. However, it is the REB that isresponsible for deciding how these conflicts shall be managed. This includes re-quiring that researchers disclose institutional conflicts of interest that are relevantto participant consent. These decisions must be documented in accordance withArticle 6.17.

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Community-based research involving small communities or community-basedorganizations with scarce human resources may present particular issues related tomultiple roles of some individuals. In some cases, securing informed advice oncultural or other aspects of research rests with the researcher or the sponsoringinstitution, and requires engagement with a community advisor who may assumevarious roles in the research process. The same individual may be involved inproviding preliminary information as well as reviewing the ethics of a researchproposal at the community level and/or possibly co-managing the approvedresearch. As outlined in Article 7.1, an approach relative to the level of risks, suchas disclosure to the participants of the possible conflicts between multiple roles,may be sufficient to manage the conflict (see also Articles 9.6, 9.8 and 9.12).

C. REB Members and Conflicts of Interest

Article 7.3 When reviewing research proposals, REB members shall disclose real, potentialor perceived conflicts of interest to the REB. When necessary, the REB may decidethat some of its members must withdraw from REB deliberations and decisions.

Application To maintain the independence and integrity of research ethics review, members ofthe REB must identify, eliminate, minimize or otherwise manage real, potential orperceived conflicts of interest. If an REB is reviewing a research project in whicha member of the REB has a personal or financial conflict of interest (see Section Aof this chapter), the member must disclose the nature of the conflict and absentthemselves from any discussion or decision regarding that research project. In theevent that a member’s conflict of interest and necessary withdrawal from the meet-ing will threaten the maintenance of quorum, the REB can ensure that a substitutemember be in attendance to maintain quorum.

Conflict of interest policies should determine a reasonable time period during whichan REB member is not allowed to review a proposal involving a recent collaborator,supervisor, student or other colleague (as defined by the institution). The purposeof these policies on time limits is to ensure adequate and continued access to com-petent expertise. In some cases, the scientific expertise of the REB member maystill be sought when no other individuals with the scientific expertise relevant tothe proposal under review are available to the REB. In such instances, the REBwill record this explicitly in the minutes. The member should not be present whenthe REB makes its decision.

REBs and Senior Administrators

Institutional senior administrators (e.g., a vice-president of research or business de-velopment) should not serve on an REB, or directly or indirectly influence the REBdecision-making process. The mere presence of an institutional senior administratorat REB meetings may undermine the independence of the REB by unduly influ-encing REB deliberations and decisions.

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REBs and senior administrators should consider other venues to discuss policy is-sues, general issues arising from the REB’s activities, or training and educationalneeds, to the benefit of the overall operation and mandate of the REB. In the dis-charge of their interdependent roles and duties to participants, effectivecommunications processes should be established between REBs and the relevantofficers of institutions. In cases where senior administrators interfere with the REBdecision-making process, REBs should invoke the institution’s conflict of interestpolicies.

Compensation for REB members

Reasonable compensation by institutions for work done by REB members is ap-propriate. However, in some instances, individual members of the REB may havea conflict of interest in accepting undue or excessive honoraria for their participa-tion in the REB. Institutions should define appropriate levels of compensation.

D. Researchers and Conflicts of Interest

Article 7.4 Researchers shall disclose in research proposals they submit to the REB any real,potential or perceived individual conflicts of interest, as well as any institutionalconflicts of interest of which they are aware that may have an impact on their re-search. Upon discussion with the researcher, the REB shall determine theappropriate steps to manage the conflict of interest.

Application Managing conflict of interest is a process that begins with identification and is fol-lowed by disclosure. Upon disclosure of a conflict by a researcher to the REB, thesteps taken by the REB to manage the conflict should be context-based and com-mensurate with the risks. In some cases, the REB might conclude that the identifiedconflict of interest does not warrant further action.

The REB should require, consistent with Article 3.2(e), that the researcher discloseany real, potential or perceived conflict of interest to the participant. When disclo-sure to the REB is not enough to manage the conflict of interest, the REB, guidedby established institutional policies, may require that the researcher withdraw fromthe research, or that others on the research team, who are not in conflict of interest,make research-related decisions. Where appropriate, disclosure to the sponsor, theinstitution and any relevant professional body may also be necessary. In exceptionalcases, the REB has the discretion to refuse approval of a research project wherethe REB decides that the conflict of interest has not been avoided or cannot be ap-propriately managed.

If there is a need for a researcher with a conflict of interest in a research project tobe involved in some aspect of the project, the extent of the involvement should bereviewed and explicitly endorsed by the REB in its minutes. Participants shouldalso be informed during the consent process of the conflict and the extent of the

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researcher’s involvement. In line with the proportionate approach to REB review,and through the continued research ethics review process, REBs may impose ad-ditional control mechanisms if necessary.

Dual Roles

Dual roles of researchers and their associated obligations (e.g., acting as both a re-searcher and a therapist, health care provider, caregiver, teacher, advisor, consultant,supervisor, student or employer) may create conflicts, undue influences, power im-balances or coercion that could affect relationships with others and affectdecision-making procedures (e.g., consent of participants). Article 3.2(e) remindsresearchers of relevant ethical duties that govern real, potential or perceived con-flicts of interest as they relate to the consent of participants.

To preserve and not abuse the trust on which many professional relationships rest,researchers should be fully cognizant of conflicts of interest that may arise fromtheir dual or multiple roles, their rights and responsibilities, and how they can man-age the conflict. When acting in dual or multiple roles, the researcher shall disclosethe nature of the conflict to the participant in the consent process.

Financial Conflicts of Interest

Real, potential or perceived financial conflicts of interest may affect any type ofresearch. Researchers and REBs should be aware of, and consider, the possibilityof financial conflicts of interest. They should seek to ensure that financial consid-erations do not serve to diminish respect for the principles of this Policy or thescientific validity and transparency of research procedures.

Financial incentives have the potential to distort researchers’ judgment in ensuringthe design and conduct of research is ethical. When researchers partner with or-ganizations whose primary motive is profit, they must be aware of the potentialfor conflicts of interest. Consideration for the profitability of the research maythreaten the ethical integrity of research design and conduct. Not all research spon-sored by for-profit organizations gives rise to financial conflicts of interest.However, REBs shall consider the potential for this type of conflict because itsability to undermine the ethical conduct of research has been empirically estab-lished.

As part of a research project submitted for REB review, researchers shall discloseall kinds and amounts of payment (financial or in-kind) to the researchers by spon-sors, commercial interests, and consultative or other relationships, as well as anyother relevant information that may affect the project (e.g., donation to an institu-tion by a research sponsor). Researchers shall also supply all relevantdocumentation and identify strategies to prevent, disclose, minimize or otherwisemanage conflicts.


The REB should examine budgets to ensure that there are no inappropriate pay-ments to be made or other unexplained expenses that may raise questions aboutconflict of interest. Further, payment provisions should be scrutinized to ensurethey do not create ethically inappropriate incentives to recruit quickly, at the ex-pense of a careful review of the suitability of prospective participants.Unreasonable payments or undue inducements may place the researcher, and some-times the institution, in a conflict between maximizing financial remuneration onthe one hand and protecting participants and meeting the scientific requirementsof the project on the other. Disclosure of the kinds and amounts of payments andother budgetary details encourages the researcher to identify and appropriatelymanage potential conflicts of interest and helps the REB to assess them. Manage-ment by institutions and/or REBs may include prohibiting certain forms ofpayment.

The perception of a conflict of interest may, in many cases, be as damaging as areal conflict. The REB should assess the likelihood that the researcher’s judgmentmay be inappropriately influenced, or perceived to be influenced, by private or per-sonal interests. It should then determine the magnitude of harm that is likely toresult from such influence or from the perception of undue influence.

In addressing conflicts of interest, disagreements between the REB and the re-searcher may arise about the scope and reach of disclosure, including disclosure ofnew information to participants, or other aspects of managing the conflict. Reso-lution of disagreements should be guided by the paramount principles of Respectfor Persons and Concern for Welfare of participants. If the researcher and the REBcannot resolve their disagreement they should use the institutional conflict of in-terest mechanisms to arrive at a solution.

Endnote

1 Definition of “conflict of interest” adapted from the definition in Agreement on the Administration ofAgency Grants and Awards by Research Institutions.

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Chapter 8MULTI-JURISDICTIONAL RESEARCH

Introduction

This chapter sets out options, procedures and considerations for the ethics review of multi-juris-dictional research either entirely within Canada, or in Canada and other countries. It is intendedto facilitate the ethics review process and ethical conduct of such research while ensuring that allparticipants are afforded the same respect and protection in accordance with the core principles ofthis Policy.

Contemporary research often involves collaborative partnerships among researchers from multipleinstitutions or countries. It may call upon the participation of a number of local populations andinvolve multiple institutions and/or multiple research ethics boards (REBs).

Collaborations in research may require institutions to adopt policies and procedures that permitarrangements for REB review by REBs at other institutions or external or independent REBs. Tobe effective, these review arrangements should ensure that research involving humans is designed,reviewed, and conducted in a way that is informed by the core principles of this Policy: Respectfor Persons, Concern for Welfare, and Justice. These core principles should be balanced with aproportionate approach to the research ethics review process (described in Article 2.9) for researchbeing undertaken in Canada or abroad. Multi-jurisdictional research should take into account otherrelevant policies, and applicable laws and regulations.

A. Review Mechanisms for Research Involving Multiple Institutions and/or Multiple REBs

This section primarily addresses the ethics review mechanisms for research involving multiple in-stitutions and/or multiple REBs. It is not intended to apply to ethics review mechanisms forresearch involving multiple REBs within the jurisdiction or under the auspices of a single institu-tion (addressed in Article 6.3).

Research involving humans that may require the involvement of multiple institutions and/or mul-tiple REBs includes, but is not limited to, the following situations:

(a) a research project conducted by a team of researchers affiliated with different institutions;

(b) several research projects independently conducted by researchers affiliated with differentinstitutions, with data combined at some point to form one overall research project;

(c) a research project conducted by a researcher affiliated with one institution, but that involvescollecting data or recruiting participants at different institutions;

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(d) a research project conducted by a researcher who has multiple institutional affiliations(e.g., two universities, a university and a college, or a university and a hospital. SeeApplication of Article 6.1);

(e) a research project conducted by a researcher at one institution that requires the limited col-laboration of individuals affiliated with different institutions or organizations (e.g.,statisticians, lab or X-ray technicians, social workers and school teachers); or

(f) a research project that researcher(s) working under the auspices of a Canadian research in-stitution conduct in another province, territory or country.

Adoption of Alternative Review Models – An Institutional Responsibility

Article 8.1 An institution that has established an REB may approve alternative review modelsfor research involving multiple REBs and/or institutions, in accordance with thisPolicy. The institution remains responsible for the ethical acceptability and ethicalconduct of research undertaken within its jurisdiction or under its auspices irre-spective of where the research is conducted.

Application As described in Chapter 6, institutions are accountable for research conducted undertheir auspices, irrespective of the location where it takes place. Where research in-volving humans requires the involvement of multiple institutions and/or multipleREBs, an institution may establish one or more, or a mix of models for researchethics review as described below. Institutions may also establish other models orarrangements that are appropriate for the research under review within their juris-diction or under their auspices. The ultimate responsibility for approving alternativeresearch ethics review models for potential use by REBs and researchers remainswith their individual institutions.

In consultation with its REB(s), an institution may authorize its REB to accept re-views undertaken by an external REB of the ethical acceptability of research. Thisauthorization should be based on an official agreement that includes, but is not lim-ited to, the following minimum components:

• all institutions or equivalent organization(s) involved agree to (1) adhere to therequirements of this Policy, (2) formalize the cross-institutional agreement, and(3) document the existence of this agreement in their institutional policies;

• the highest institutional level, the body that originally defined the jurisdictionof the REB and its relationship to other relevant bodies or authorities withinthe institution, makes the decision to allow an REB to recognize research ethicsreview decisions made by another REB (in accordance with Article 6.2); and

• approvals based on cross-institutional agreement should be documented andreported to the full REB, through the REB Chair, in each institution. The pointin reporting is informational. It should not necessarily trigger a duplicate re-search ethics review.

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Researchers and REBs should use the research ethics review models defined bytheir institution (see Article 8.2) and facilitate coordination of the research ethicsreview process. Whatever model is chosen, roles and responsibilities of all involvedin the process should be defined and agreed to at the outset. Continuing ethics re-view of research involving multiple institutions and/or multiple REBs shouldfollow the same process outlined in Article 6.14.

Research Ethics Review Models

The following models for the ethics review of research involving multiple REBs and/or multipleinstitutions are intended to provide flexibility and efficiency, and avoid unnecessary duplicationof review without compromising the protection of participants. All other provisions of this Policyremain applicable.

1) Independent Ethics Review by Several REBs

This model follows the same research ethics review process as when the research only involves asingle REB review. The REBs involved at each participating institution conduct an independentresearch ethics review and provide their separate decisions, either concurrently or sequentially.The level of ethics review for research that involves multiple REBs and/or institutions shall beproportionate to the risk involved in the research (see Article 6.12).

Ethics review of the proposed research at each collaborating institution helps to ensure that localissues and values are taken into consideration. This approach may be particularly important, thoughoften more challenging, when there are relevant social or cultural differences between the partic-ipating institutions. When several REBs consider the same proposal from their own institutionalperspectives, they may reach different conclusions on one or more aspects of the proposed research,that reflect local issues and values. REBs may therefore wish to coordinate their ethics review ofresearch projects requiring multiple REB involvement, including conducting their research ethicsreviews in a timely manner, and communicating any concerns that they may have with other REBsreviewing the same project. When multiple REBs are involved, the principal investigators shouldwork with their REBs to formulate a strategy to address procedural inconsistencies or substantivedisagreements that may arise among the participating REBs.

Where possible, researchers should provide their REB with the name and contact information ofthe other REBs that will also review the project to facilitate direct communication between theREBs, and help resolve disagreements that may arise.

2) Research Ethics Review Delegated to an External, Specialized or Multi-Institutional REB

Institutions may allow research on specialized content or research methods to be reviewed by anexternal, specialized or multi-institutional REB, where such a body exists. External, specializedor multi-institutional REBs may be established regionally, provincially/territorially or nationally,as necessary. Two or more institutions may choose to create a single joint REB, or to appoint anexternal REB, to which they delegate research ethics review. This delegation of review may bebased on geographical proximity or other considerations such as resources, volume of reviews orshared expertise.

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Some provinces have introduced legislation or policies that designate one or more REBs for thereview of certain types of research within the province (see References at the end of this chapter).

In the official agreement between the selected REB and the institutions submitting research forethics review, the external, specialized, or multi-institutional REB shall agree to adhere to thisPolicy. Roles and responsibilities should be clearly defined in the official agreement between theinstitution(s) delegating the review, and the institution or equivalent organization of the REB thatwill review the ethical acceptability of the research, or in the relevant legislation or policies. Theexternal, specialized or multi-institutional REB may act as the responsible REB for any given review,if formally mandated as such by the institutions in question. Where relevant, agreements shouldspecify how the external, specialized or multi-institutional REB will assure familiarity withparticular populations that may be involved in the research. Review by an external, specialized ormulti-institutional REB need not be preceded or followed by local REB review unless warrantedto help ensure that local issues and values are taken into account.

3) Reciprocal REB Review

Multiple institutions may enter into official agreements under which they will accept, with anagreed level of oversight, the research ethics reviews of each other’s REBs. This might involvespecific agreements between institutions for sharing their workload. Alternatively, institutions maydecide that reciprocity agreements should be established for the ethics review of each relevantresearch proposal on a case-by-case basis.

In either case, researchers shall ensure that the reviewing REB is provided with any relevant in-formation about the local populations and circumstances that would ordinarily be available to thelocal REB, and that may have a bearing on its review. The reviewing REB might call upon localREBs to provide information in addition to that provided by the researchers.

Selection of a Research Ethics Review Model Relevant to the Research Project

Article 8.2 When planning a research project involving multiple institutions and/or multipleREBs, researchers and REBs should select the most appropriate research ethicsreview model from among those authorized by their institution.

Application Sensitivity to context is a key issue in the application of the core principles of thisPolicy to the ethics review of research involving multiple institutions and/or REBs.Researchers should consider the alternative research ethics review models at theplanning and design stage of their research, and should consult with their REB tofacilitate the selection and coordination of the appropriate review model. In choosingthe appropriate research ethics review model, the researcher and the REB shouldpay attention to the research context, and the characteristics of the populations tar-geted by the research. The final decision regarding the selection of the appropriatemodel is the responsibility of the principal REB.

When selecting from among research ethics review models authorized by their in-stitution, researchers and REBs should consider the following:

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• the discipline and content area of the research, and the availability of appropri-ate experience and expertise within, or available to, the reviewing REB;

• the scope of the project to be reviewed and appropriateness of the proposedresearch ethics review model;

• the vulnerability of the study population overall and/or the particular charac-teristics of the local population at individual sites, differences in values andcultural norms, and the level of risk associated with the research under review;

• any relevant differences in laws and/or guidelines pertaining to the researchin question if the institutions are in different provinces, territories and/orcountries;

• relationships between institutions and REBs, and conflict resolution mecha-nisms related to REB decisions;

• the potential for conflicts of interest and undue influence, including those thatmay arise from funding sources;

• any differences in the standard of care normally followed, or access to servicesat the participating institutions that might be relevant to the conduct of theresearch; and

• any operational issues that might affect the research.

B. Ethics Review of Research Conducted outside the Institution

Researchers affiliated with Canadian institutions are undertaking research at numerous sites withinCanada and in countries around the world. Such research may be carried out with or without anycollaboration with host institutions and local researchers. Most middle-income countries, and manylow-income countries, have laws, policies or guidelines governing the ethical conduct of researchinvolving humans, but some parts of the world do not have developed or widespread researchethics infrastructure.

National and international standards for research involving humans are evolving continually, butmethods for comparing the precise levels of protection afforded to participants in differentcountries or jurisdictions, and by different institutions within those countries and jurisdictions,have not yet been developed. In exercising its responsibilities for the initial and continuing ethicsreview of research conducted under its auspices, the Canadian REB shall satisfy itself that therequirements of this Policy are met, both within the Canadian institution, and within the othercountry or research site. The Canadian REB shall take appropriate steps to ensure researchers areresponsive to ethically relevant aspects of the research context.

Article 8.3 (a) Where research conducted under the auspices of a Canadian research institutionand performed in whole or in part outside of Canada has been approved undera research ethics review model involving multiple institutions and/or REBsconsistent with this Policy, the terms of that model apply.

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(b) Subject to Article 8.3(a), research conducted under the auspices of a Canadianresearch institution and conducted outside its jurisdiction, whether elsewherein Canada, or outside Canada, shall undergo prior research ethics review byboth:

i. the REB at the Canadian institution under the auspices of which the research is being conducted; and ii. the REB or other responsible review body or bodies, if any, at the research site.

Application An institution is responsible for the ethical conduct and ethical acceptability of re-search undertaken by its faculty, staff or students regardless of where the researchis conducted (see Article 6.1). Thus, for a Canadian research institution, review ofthe ethical acceptability of the research by the institution’s REB is required, in ad-dition to ethics review by an REB or other appropriately constituted review bodywith jurisdiction at the research site elsewhere in Canada, or outside Canada, ifany. Approval of a research proposal by an REB at the research site does not con-stitute sufficient authorization to conduct the research without the approval of therelevant Canadian REB(s). Conversely, approval by the Canadian REB(s) is notsufficient authorization to begin the research without the approval of the REB orother appropriately constituted review body at the research site. Researchers shallobtain necessary approvals of the ethical acceptability of their research prior to thestart of recruitment of participants, access to data, or collection of human biologicalmaterials, in accordance with Article 6.11.

Researchers may undertake research in Canada or abroad without formal collabo-ration with other academic institutions. In these cases, in addition to the REBreview at their own institution, researchers may need to obtain access to the siteand prospective participants from a responsible agency, where one exists. Theyshall inform the REB whether, or how, they will seek permission to proceed withthe research at that site and with the target participants. Some organizations orgroups have established mechanisms or guidelines (e.g., school boards, Aboriginalcommunities [see Chapter 9], correctional services, service agencies and commu-nity groups) to review requests for research prior to allowing access to theirmembers, or access to data about them that are under their authority. When design-ing their research, researchers should consider these provisions. This article doesnot apply to research involving critical inquiry about organizations or institutions(see Article 3.6).

Researchers shall inform the REB of the absence of established ethics review mech-anisms at the research site, and report their efforts to identify any other suitablereview mechanisms in the other country.1 When no appropriate mechanisms forresearch ethics review exist at the research site, researchers and REBs shall applythe core principles outlined in this Policy (see Chapter 1).

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REBs should not prevent research from proceeding solely because the researchcannot be reviewed and approved through a formal REB review process in anothercountry or other jurisdiction. Under these circumstances, researchers should beaware of relevant cultural practices, such as those normally followed to seek entryinto the relevant communities, and be respectful of them. Researchers shall informthe REB of their strategies to familiarize themselves with the relevant norms andcultural practices, and to minimize risks to individuals and communities partici-pating in, or potentially affected by, the research.

Researchers and REBs should afford prospective participants in other countries noless protection and respect than what this Policy requires. Respect for Persons,Concern for Welfare, and Justice considered in the context of the particular researchproject and setting should guide researchers in the design of their research, andREBs in their research ethics review.

Article 8.4 (a) The information to be provided to the researcher’s home REB will be deter-mined by the provisions of the research ethics review model.

(b) When conducting research outside the jurisdiction of their home institution,whether at a site abroad, or in Canada, researchers shall provide their homeREBs with:

• the relevant information about the rules governing research involving hu-mans and the ethics review requirements at the research site, where any exist;

• the names and contact information for the relevant REBs or comparableethics bodies, if known, that will review the proposal at the research site;and

• relevant information about the target populations and circumstances thatmight have a bearing on the research ethics review by the researchers’ homeREB.

Application Researchers and REBs should be aware of the research ethics requirements and thetypes of protections for research involving humans, including legal protection,afforded to participants at proposed research locations. Researchers and REBsshould consult relevant reliable resources for details about governing laws orpolicies, and for information regarding appropriate REBs at the proposed researchsite in Canada or another country (see References at the end of this chapter).Applicable policies at the proposed site may differ considerably from this Policy,and therefore it is the responsibility of the researchers and REB(s) to ensure that,at a minimum, the provisions of this Policy, are followed.

Disagreements may arise when one of the REBs or equivalent review body(Canadian or foreign) grants ethics approval while the other does not. Suchdisagreements require open communication among the researchers and the REBs,or equivalent review bodies involved (see also Section A of this chapter). In keeping

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with the context-sensitive approach to research ethics review embodied in thisPolicy, the Canadian REB should ensure that it has a clear understanding of thediffering rationales that might underlie divergent REB positions or decisions on agiven proposal. Where the REB is uncertain about the appropriate course of actionin a given research proposal, it should make contact with its counterpart REB inthe research site or country. In the absence of formal reciprocity agreementsbetween countries or institutions with respect to initial and continuing researchethics review, the REBs should engage in dialogue and may establish a specificmechanism, such as a joint subcommittee of the two REBs (e.g., for situations inwhich institutions collaborate regularly), to facilitate appropriate deliberation inorder to reach a thoughtful and well-informed judgment on the ethical acceptabilityof a given research proposal (see Article 8.1).

Endnote

1 See for example the United States Office for Human Research Protections (OHRP) registry of REBs(see References below), mainly in the area of health and biomedical research. It can serve as one re-source for identifying research ethics review bodies around the world.

References

• Council for International Organizations of Medical Sciences (CIOMS). International EthicalGuidelines for Biomedical Research Involving Human Subjects. CIOMS: Geneva. 2002.

• Newfoundland and Labrador. Health Research Ethics Authority Act, S.N.L. 2006, c. H-1.2.

• Québec. Ministère de la Santé et des Services sociaux. Direction générale adjointe de l’évaluation,de la recherche et de l’innovation. Unité de l’éthique. Mécanisme encadrant l’examen éthique et lesuivi continu des projets multicentriques. In effect since April 1, 2008.

• U.S. Department of Health and Human Services. Office for Human Research Protections.International Compilation of Human Research Protections, 2010 Edition.

• ———. Federal-Wide Assurances Registry for Registered Organizations Operating InstitutionalReview Boards (IRBs) or Registered IRBs.

• World Medical Association. Declaration of Helsinki – Ethical Principles for Medical ResearchInvolving Human Subjects. 2008.

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Chapter 9RESEARCH INVOLVING THE FIRST NATIONS, INUIT AND MÉTIS

PEOPLES OF CANADA

Introduction

PreambleThis chapter on research involving Aboriginal peoples in Canada, including Indian (First Nations1),Inuit and Métis peoples, marks a step toward establishing an ethical space for dialogue on commoninterests and points of difference between researchers and Aboriginal communities engaged inresearch.

First Nations, Inuit and Métis communities have unique histories, cultures and traditions. Theyalso share some core values such as reciprocity – the obligation to give something back in returnfor gifts received – which they advance as the necessary basis for relationships that can benefitboth Aboriginal and research communities.

Research involving Aboriginal peoples in Canada has been defined and carried out primarily bynon-Aboriginal researchers. The approaches used have not generally reflected Aboriginal worldviews, and the research has not necessarily benefited Aboriginal peoples or communities. As aresult, Aboriginal peoples continue to regard research, particularly research originating outsidetheir communities, with a certain apprehension or mistrust.

The landscape of research involving Aboriginal peoples is rapidly changing. Growing numbersof First Nations, Inuit and Métis scholars are contributing to research as academics and communityresearchers. Communities are becoming better informed about the risks and benefits of research.Technological developments allowing rapid distribution of information are presenting bothopportunities and challenges regarding the governance of information.

This chapter is designed to serve as a framework for the ethical conduct of research involvingAboriginal peoples. It is offered in a spirit of respect. It is not intended to override or replaceethical guidance offered by Aboriginal peoples themselves. Its purpose is to ensure, to the extentpossible, that research involving Aboriginal peoples is premised on respectful relationships. It alsoencourages collaboration and engagement between researchers and participants.

Building reciprocal, trusting relationships will take time. This chapter provides guidance, but itwill require revision as it is implemented, particularly in light of the ongoing efforts of Aboriginalpeoples to preserve and manage their collective knowledge and information generated from theircommunities. The Agencies – the Canadian Institutes of Health Research (CIHR), the NaturalSciences and Engineering Research Council (NSERC), and the Social Sciences and HumanitiesResearch Council (SSHRC) – are committed to the continued evolution of this Policy, as noted inthe Introduction. As the Policy comes into effect, the approach of engaging communities will be

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applied not only to research projects but also to the further development of the Policy itself toensure that it remains a living document.

This chapter forms an integral part of this Policy to which institutions eligible to administer andreceive research funding from any of the three research agencies agree to adhere as a condition offunding (see the Agreement on the Administration of Agency Grants and Awards by ResearchInstitutions). It has drawn on prior work, both within Canada and internationally, that recognizesthe interests of Aboriginal peoples who participate in research and are affected by its results. Someof that work has been done by the three agencies responsible for this Policy. In particular, theCIHR and its Institute of Aboriginal Peoples’ Health have engaged in extensive dialogue withcommunity partners to develop the CIHR Guidelines for Health Research Involving AboriginalPeople. The CIHR Guidelines remain an important source of additional guidance for healthresearch involving Aboriginal peoples in Canada.

SSHRC and NSERC, likewise, have developed program guidelines for research involvingAboriginal peoples and issues. Aboriginal entities at local, regional and national levels havepublished and implemented principles and codes governing research practice – including ethicalprotections – that emphasize collective rights, interests and responsibilities.

This Policy provides guidance for research involving humans, as defined in Chapter 2. Otherguidelines specific to particular programs, research domains and community settings may elaborateon the processes set out herein, or may address ethical concerns of broader scope than thosecovered in this Policy. Researchers and research ethics boards (REBs) are advised to consultreference documents that apply to their research undertaking. Examples of relevant resources arelisted under References at the end of this chapter.

While this chapter is designed to guide research involving First Nations, Inuit and Métis Peoplesof Canada, its discussion of respectful relationships, collaboration and engagement betweenresearchers and participants may also be an important source of guidance for research involvingother distinct communities. The need to respect a community’s cultural traditions, customs andcodes of practice may extend beyond First Nations, Inuit and Métis communities. REBs andresearchers may draw on articles of this chapter that are of relevance for the particular communityinvolved in the research.Neither this Policy nor this chapter are meant to reflect or introduce any change to otherGovernment of Canada policies with respect to the issues addressed in this chapter.

Context

The existing Aboriginal and treaty rights of the Aboriginal peoples of Canada, that is, the Indian,Inuit and Métis peoples of Canada, were recognized and affirmed in the Constitution Act, 1982.2

This chapter acknowledges the unique status of the Aboriginal peoples of Canada. It interpretshow the value of respect for human dignity and the core principles of Respect for Persons, Concernfor Welfare, and Justice (as articulated in Chapter 1) apply to research involving Aboriginalpeoples. It accords respect to Aboriginal peoples’ knowledge systems by ensuring that the variousand distinct world views of Indian, Inuit and Métis peoples are represented in planning and decision

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Chapter 9 – Research Involving First Nations, Inuit and Métis Peoples of Canada


making, from the earliest stages of conception and design of projects through to the analysis anddissemination of results. It affirms respect for community customs and codes of research practiceto better ensure balance in the relationship between researchers and participants, and mutual benefitin researcher-community relations.

The purpose of this chapter specifically, and the Policy in general, is to provide guidance toresearchers on the ethical conduct of research involving Aboriginal peoples.

The desire to conserve, reclaim and develop knowledge specific to First Nations, Inuit and Métiscommunities, and to benefit from contemporary applications of traditional knowledge, is amotivating force in community initiatives to assume a decisive role in research. The guidanceprovided in this chapter is based on the premise that engagement with community is an integralpart of ethical research involving Aboriginal peoples.

This Policy acknowledges the role of community in shaping the conduct of research that affectsFirst Nations, Inuit and Métis communities. The Policy also respects the autonomy of individualsto decide whether they will participate in research in accordance with Articles 3.1 to 3.6. Articlesin this chapter give guidance for balancing individual and collective interests. In light of thediversity within and among First Nations, Inuit and Métis communities, and the ongoingdevelopment of community codes of research practice by these communities at the local, regionaland national level, ethical review of a proposed project shall be attentive to the specific context ofthe project and the community involved (see Articles 9.8 and 9.9).

A. Key Concepts and Definitions

Definitions of key concepts used in this chapter are provided to assist in applying the guidance inthis Policy (see Chapter 1 regarding the scope of definitions used in this Policy) and to facilitatedialogue between researchers and Aboriginal communities. Since there is not universal agreementon the meaning of some terms, the definitions provided are intended for the purposes of this Policyonly. This terminology will require periodic revision, particularly in light of the ongoing debateon the terms of art used in international and domestic contexts. This is in keeping with acommitment to the continued evolution of this Policy.

• Aboriginal peoples – include persons of Indian, Inuit or Métis descent regardless of wherethey reside and whether or not their names appear on an official register. The term“Aboriginal” fails to reflect the distinctions among First Nations, Inuit and Métis peoples,who have their own histories, cultures and languages, so an attempt has been made to limituse of the term in this Policy to instances where a global term is appropriate. Indian peoplescommonly identify themselves by distinct nation names such as Mi’kmaq, Dene or Haida,and as First Nations. In the international context, the term comparable to Aboriginal peoplesis Indigenous peoples.

• Community – describes a collectivity with shared identity or interests, that has the capacityto act or express itself as a collective. In this Policy, a community may include membersfrom multiple cultural groups. A community may be territorial, organizational or a com-

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munity of interest. “Territorial communities” have governing bodies exercising local orregional jurisdiction (e.g., members of a First Nations resident on reserve lands). “Organi-zational communities” have explicit mandates and formal leadership (e.g., a regional Inuitassociation or a friendship centre serving an urban Aboriginal community). In both terri-torial and organizational communities, membership is defined and the community hasdesignated leaders. “Communities of interest” may be formed by individuals or organiza-tions who come together for a common purpose or undertaking, such as a commitment toconserving a First Nations language. Communities of interest are informal communitieswhose boundaries and leadership may be fluid and less well-defined. They may exist tem-porarily or over the long term, within or outside of territorial or organizational communities.

An individual may belong to multiple communities, both Aboriginal and non-Aboriginal(e.g., as a member of a local Métis community, a graduate students’ society and a coalitionin support of Aboriginal rights). An individual may acknowledge being of First Nations,Inuit or Métis descent but not identify with any particular community. How individualsdefine which of their community relationships are most relevant will likely depend on thenature of the research project being proposed.

• Community customs and codes of research practice – may be expressed in written or oralform. Consistent with the world views of particular First Nations, Inuit and Métis peoples,community customs and codes of research practice may embody kinship networks andresponsibilities that include multi-generational obligations to ancestors and futuregenerations. Ethical obligations often extend to respectful relations with plant, animal andmarine life.

• Community engagement – is a process that establishes interaction between a researcher orresearch team, and the Aboriginal community relevant to the research project. It signifiesa collaborative relationship between researchers and communities, although the degree ofcollaboration may vary depending on the community context and the nature of the research.The engagement may take many forms including review and approval from formalleadership to conduct research in the community, joint planning with a responsible agency,commitment to a partnership formalized in a research agreement, or dialogue with anadvisory group expert in the customs governing the knowledge being sought. Theengagement may range from information sharing to active participation and collaboration,to empowerment and shared leadership of the research project. Communities may alsochoose not to engage actively in a research project, but simply to acknowledge it andregister no objection to it.

• First Nations, Inuit and Métis lands – include Indian reserves, Métis settlements, and landsgoverned under a self-government agreement or an Inuit or First Nations land claimagreement.

• Indigenous knowledge – see traditional knowledge, below.

• Indigenous peoples – a term used in international or scholarly discourse; there is noconsensus on the definition of the term “indigenous.” In some countries, other terms maybe used. Self-identification is a fundamental criterion for defining Indigenous peoples.

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• Traditional knowledge – the knowledge held by First Nations, Inuit and Métis peoples, theAboriginal peoples of Canada. Traditional knowledge is specific to place, usuallytransmitted orally, and rooted in the experience of multiple generations. It is determinedby an Aboriginal community’s land, environment, region, culture and language. Traditionalknowledge is usually described by Aboriginal peoples as holistic, involving body, mind,feelings and spirit. Knowledge may be expressed in symbols, arts, ceremonial and everydaypractices, narratives and, especially, in relationships. The word tradition is not necessarilysynonymous with old. Traditional knowledge is held collectively by all members of acommunity, although some members may have particular responsibility for itstransmission. It includes preserved knowledge created by, and received from, pastgenerations and innovations and new knowledge transmitted to subsequent generations.In international or scholarly discourse, the terms traditional knowledge and Indigenousknowledge are sometimes used interchangeably.

B. Interpreting the Ethics Framework in Aboriginal Contexts

Chapter 1 identifies three principles that express the core ethical value of respect for human dignity– Respect for Persons, Concern for Welfare, and Justice. The three core principles are interpretedin this chapter as follows:

Respect for Persons is expressed principally through the securing of free, informed and ongoingconsent of participants. The concerns of First Nations, Inuit and Métis for their continuity aspeoples with distinctive cultures and identities have led to the development of codes of researchpractice that are in keeping with their world views. Aboriginal codes of research practice go beyondthe scope of ethical protections for individual participants, and extend to the interconnectionbetween humans and the natural world, and include obligations to maintain, and pass on to futuregenerations, knowledge received from ancestors as well as innovations devised in the presentgeneration.

Historically, the well-being of individual participants has been the focus of research ethicsguidelines. In this Policy, the principle of Concern for Welfare is broader, requiring considerationof participants and prospective participants in their physical, social, economic and culturalenvironments, where applicable, as well as concern for the community to which participantsbelong. This Policy acknowledges the important role of Aboriginal communities in promotingcollective rights, interests and responsibilities that also serve the welfare of individuals.

Aboriginal peoples are particularly concerned that research should enhance their capacity tomaintain their cultures, languages and identities as First Nations, Inuit or Métis peoples, and tosupport their full participation in, and contributions to, Canadian society. The interpretation ofConcern for Welfare in First Nations, Inuit and Métis contexts may therefore place strong emphasison collective welfare as a complement to individual well-being.

Justice may be compromised when a serious imbalance of power prevails between the researcherand participants. Resulting harms are seldom intentional, but nonetheless real for the participants.In the case of Aboriginal peoples, abuses stemming from research have included: misappropriationof sacred songs, stories and artefacts; devaluing of Aboriginal peoples’ knowledge as primitive or

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superstitious; violation of community norms regarding the use of human tissue and remains; failureto share data and resulting benefits; and dissemination of information that has misrepresented orstigmatized entire communities.

Where the social, cultural or linguistic distance between the community and researchers fromoutside the community is significant, the potential for misunderstanding is likewise significant.Engagement between the community involved and researchers, initiated prior to recruitingparticipants and maintained over the course of the research, can enhance ethical practice and thequality of research. Taking time to establish a relationship can promote mutual trust andcommunication, identify mutually beneficial research goals, define appropriate researchcollaborations or partnerships, and ensure that the conduct of research adheres to the core principlesof Respect for Persons, Concern for Welfare – which in this context includes welfare of thecollective, as understood by all parties involved – and Justice.

Research Involving Indigenous Peoples in Other Countries

Although the present chapter addresses research involving Aboriginal peoples in Canada, researchers,REBs, participants and the research community at large may find the guidance articulated here usefulwhen undertaking research or reviewing a proposal involving Indigenous peoples in other countrieswho endorse collective decision making as a complement to individual consent. It is criticallyimportant, however, to seek local guidance in the application or adaptation of this Policy toIndigenous peoples outside of Canada.

For considerations that apply to research conducted in another country, see Chapter 8, Section B.

C. Applying Provisions of This Policy in Aboriginal Contexts

Requirement of Community Engagement in Aboriginal Research

Article 9.1 Where the research is likely to affect the welfare of an Aboriginal community, orcommunities, to which prospective participants belong, researchers shall seekengagement with the relevant community. The conditions under which engagementis required include, but are not limited to:

(a) research conducted on First Nations, Inuit or Métis lands;

(b) recruitment criteria that include Aboriginal identity as a factor for the entirestudy or for a subgroup in the study;

(c) research that seeks input from participants regarding a community’s culturalheritage, artefacts, traditional knowledge or unique characteristics;

(d) research in which Aboriginal identity or membership in an Aboriginalcommunity is used as a variable for the purpose of analysis of the research data;and

(e) interpretation of research results that will refer to Aboriginal communities,peoples, language, history or culture.

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Application Paragraph (a) refers to First Nations, Inuit and Métis lands that include Indianreserves, Métis settlements and lands governed under a self-government agreementor an Inuit or First Nations land claim agreement. Researchers should becomeinformed about formal rules or oral customs that may apply in accordance with aparticular First Nations, Inuit or Métis authority. In different jurisdictions, researchactivities may be regulated in various ways.

Paragraph (c) refers to cultural heritage, which includes, but is not limited to, FirstNations, Inuit and Métis peoples’ relations with particular territories, materialobjects, traditional knowledge and skills, and intangibles that are transmitted fromone generation to the next (e.g., sacred narratives, customs, representations orpractices). Cultural heritage is a dynamic concept, in that materials, knowledge andpractices are continuously adapted to the realities of current experience.

Cultural heritage research such as archaeological research involving burial sites orsacred landscapes and handling of artefacts may raise ethical obligations importantto the Aboriginal community that may not be addressed in academic researchproposals. Researchers and communities should agree in advance on how toreconcile or address these divergent perspectives (see Articles 9.8 and 9.12).

Appropriation of collective knowledge, treatment of such knowledge as acommodity to be traded, or making unauthorized adaptations for commercialpurposes, may cause offence or harm to communities from which the knowledgeoriginates. Such conduct has prompted initiatives in various countries andinternational agencies to address unethical, unfair, and inequitable treatment oftraditional knowledge and knowledge holders (see Article 9.18).

Paragraph (e) refers to both primary collection of research data and secondary useof information collected originally for a purpose other than the current researchpurpose (see Article 2.4 and Chapter 5, Section D). Articles 9.20 to 9.22 addresscommunity engagement and individual consent for secondary use of identifiableinformation and human biological material for research purposes.

Nature and Extent of Community Engagement

Article 9.2 The nature and extent of community engagement in a project shall be determinedjointly by the researcher and the relevant community, and shall be appropriate tocommunity characteristics and the nature of the research.

Application Diversity among and within communities makes generalizations about the form ofcommunity engagement inappropriate. Diversity within Aboriginal communitiesmay encompass differences in levels of formal education and employment,mobility, generational differences and intermarriage with non-Aboriginal persons.This diversity increases the importance of clarifying mutual expectations andobligations with the community, and incorporating them into a research agreement.

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Community engagement as defined in this Policy can take varied forms. Ingeographic and organizational communities that have local governments or formalleadership, engagement prior to the recruitment of participants would normallytake the form of review and approval of a research proposal by a designated body.In less structured situations (e.g., a community of interest), a key consideration forresearchers, prospective participants and REBs is determining the nature and extentof community engagement required. In some situations, if the REB is satisfied thatparticipants are not identified with a community or that the welfare of relevantcommunities is not affected, the REB may waive the requirement of a communityengagement plan (see Article 9.10). In these cases, consent of individuals issufficient to participate.

Communities lacking the infrastructure to support pre-research communityengagement should not be deprived of opportunities to participate in guidingresearch affecting their welfare (see Article 9.14).

The following list, which is not exhaustive, provides examples to illustrate theforms of community engagement that might be appropriate for various types ofresearch.

1) Research directly involving a community on First Nations, Inuit or Métis landswith a formal governance structure. For example, a project that examines theincidence of diabetes in Pond Inlet, Nunavut, or the impact on Inuit health ofcontaminants in animals and plants used for country food.

• Permission of the Nunavut Research Institute that carries authority toapprove research in Nunavut is required. Agreement of the hamlet councilin Pond Inlet will normally be a condition of approval. The local healthcommittee may co-manage the project.

2) Research involving Aboriginal people who comprise a sizeable proportion ofthe study or community and where Aboriginal-specific conclusions areintended. For example, a comparative study of access to public housing inPrince Albert, Saskatchewan.

• First Nations in the district, represented by their tribal council, the localMétis association, and urban Aboriginal and women’s organizations maypartner with the Prince Albert city council to sponsor, implement and usethe results of the housing study.

3) Research focusing on a larger community that is known to include Aboriginalpeople (regardless of their proportion), and where Aboriginal-specificconclusions are anticipated. For example, a study of student retention in highschools in the Sault Ste. Marie district of Ontario.

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• A committee representing First Nations, Métis organizations and urbanAboriginal people whose children may be affected by the study may beconvened to advise the District Board of Education and the researchersinvolved.

4) Research involving Aboriginal people who comprise a sizeable proportion ofthe larger community that is the subject of research even if no Aboriginal-specific conclusions will be made. For example, research on employmentdevelopment programs serving residents of the inner city of Winnipeg inManitoba.

• Aboriginal service agencies or political organizations may be engaged tohelp recruit Aboriginal participants and secure community representation onan oversight committee, and to ensure cultural sensitivity in collecting andinterpreting data on employment program impacts.

5) Interviewing a sample of individuals of Aboriginal ancestry across Canada onthe impact of a policy on their lives, where the results are not attributable to, orlikely to affect, the community or communities with which they may identify.For example, survey research on the implementation of Indian Act provisionsrequiring ministerial approval of an “Indian’s” will.

• First Nations, Inuit and Métis persons, whether or not they identify asmembers of an Aboriginal community, enjoy freedom of expression as doesany citizen. They are free to consent and to participate in research projectsthat they consider to be of personal or social benefit. If the project is unlikelyto affect the welfare of the individuals’ communities, local communityengagement is not required under this Policy. The necessity or desirabilityof engaging regional or national representatives of Aboriginal communitiesin policy research may, however, be determined by other considerations.

6) Natural sciences research on First Nations, Inuit or Métis lands whereAboriginal people may act as co-investigators, or benefit from findings. Forexample, research focusing exclusively on contaminants in animals or plantsin Nunavik that does not make inferences regarding food intake.

• Research that involves the collection and analysis of tissue samples fromanimals or plants, and not involving human research participants, is notcovered within the scope of this Policy and does not require institutionalREB review. However, funding program guidelines and licensingrequirements in the North may impose obligations to engage communities.Community customs or codes of research practice may require securingregional and local permission, and reporting findings to communities (seeNSERC literature on the Northern Research Program for professors andstudents/fellows, and Article 9.8).

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7) Research that incidentally involves a small proportion of Aboriginal individualsbut is not intended to single out, or describe, characteristics of Aboriginalpeople, for example, a study of the effectiveness of therapies to control highblood pressure in a sample of hospital outpatients, which is not designed tocollect Aboriginal-specific data.

• Since Aboriginal participation is incidental rather than scheduled,community engagement is not required. If Aboriginal individuals self-identify during the collection of primary data, researchers should inquirewhether culturally appropriate assistance is desired to interpret, or supportcompliance with, the research project. However, it should be noted thatincluding markers of Aboriginal identity in data collection may revealanomalies that warrant further, more targeted research, which, if followedup, would require community engagement.

8) Research based on publicly available information as defined by this Policy, forexample, historical, genealogical or analytic research based on public records,or data available or accessible in accordance with legislation.

• Such research does not involve the collection of data from communitiesdirectly or from living persons and is not subject to REB review (see Article2.2). Community engagement is not required. Findings of such researchnevertheless may have an impact on the identity or heritage of persons orcommunities. In order to minimize any harm, researchers should seekculturally informed advice before use of such data to determine if harmsmay result and if other considerations such as sharing of the research resultsshould be explored with the original source community (see Article 9.15).

Respect for First Nations, Inuit and Métis Governing Authorities

Article 9.3 Where a proposed research project is to be conducted on lands under the jurisdictionof a First Nations, Inuit or Métis authority, researchers shall seek the engagementof formal leaders of the community, except as provided under Articles 9.5, 9.6 and9.7.

Research ethics review by the institutional REB and any responsible communitybody recognized by the First Nations, Inuit or Métis authority (see Articles 9.9 and9.11) is required in advance of recruiting and securing consent of individuals.

Application Formal leaders with governance responsibilities on First Nations, Inuit or Métisland are charged with protecting the welfare of the community. Article 8.3(b) appliesin such cases, requiring ethics review of research proposals by both “(i) the REB atthe Canadian institution under the auspices of which the research is beingconducted, and (ii) the REB or other responsible review body or bodies, if any, atthe research site.” A local authority may approve research or delegate responsibility

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for reviewing research proposals to a local or regional body (e.g., the local healthboard or a body like the Mi’kmaq Ethics Watch).

Research involving multiple geographic communities raises complex issues ofreview and approval. Regional bodies or national organizations may facilitateresearch ethics review and make recommendations, but the decision to participatenormally rests with the local communities.

Engagement with formal leadership is not a substitute for seeking consent fromindividual participants, as required by Chapter 3.

Engagement with Organizations and Communities of Interest

Article 9.4 For the purposes of community engagement and collaboration in researchundertakings, researchers and REBs shall recognize Aboriginal organizations,including First Nations, Inuit and Métis representative bodies, and serviceorganizations and communities of interest, as communities. They shall alsorecognize these groups through representation of their members on ethical reviewand oversight of projects, where appropriate.

Application Organizational communities and communities of interest may exist within theboundaries of territorial communities. Overlapping interests in these cases areconsidered in Articles 9.5 and 9.6. A majority of persons who self-identify asAboriginal live in rural and urban communities outside of discrete First Nations,Métis or Inuit communities. Political organizations, friendship centres, housingassociations, health access centres and other groups operating in rural or urbancentres have been created to enhance the welfare of their own members or thepopulations that they serve. Organizations and communities of interest are potentialpartners in research on issues relevant to their communities, and are to berecognized as communities for the purposes of community engagement under thisPolicy.

An organization may participate in research focusing on its members (e.g., theboard and staff of a friendship centre), or it may facilitate ethical engagement withthe population that it serves (e.g., the clientele of a health access centre). Acommunity of interest (e.g., Aboriginal youth who use an urban service program)may designate a local organization to provide advice and ethical protection for aproject in which they participate.

Prospective participants may not necessarily recognize organizational communitiesor communities of interest as representing their interests. Where researchers andorganizational communities or communities of interest collaborate in research (e.g.,through a research agreement), prospective participants shall be informed aboutthe extent of such collaboration (including how data will be shared) as part of theinitial and ongoing consent process (see Article 3.2[i]).

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Complex Authority Structures

Article 9.5 Where alternatives to securing the agreement of formal leadership are proposedfor research on First Nations, Inuit or Métis lands or in organizational communities,researchers should engage community processes and document measures taken, toenable the REB to review the proposal with due consideration of complexcommunity authority structures.

Application Researchers and REBs should not assume that approval of a project by formalleaders is the only avenue for endorsing a project. In some communities and somedomains of knowledge, authority to permit and monitor research rests withknowledge keepers designated by custom rather than by election or appointment.In First Nations settings, a confederacy council spanning several communities maybe recognized as having authority over its members’ traditional knowledge. In anInuit community, the hamlet council, an Elders’ circle, and a hunters and trappersorganization may have overlapping responsibility and expertise with respect to theknowledge being sought. Métis Elders dedicated to conserving Michif languagemay assert their autonomy from political leaders, but choose to collaborate witheducational or cultural agencies (see also Article 9.15).

The preferred course is to secure approval for research from both formal leadersof a community and customary authority. This is especially important for outsidersto communities, whose presence or intentions might be challenged as inappropriate.Researchers should engage community processes, including the guidance of moralauthorities such as Elders, to avert potential conflict. These measures should bedocumented to assist the REB in considering the community engagement processesproposed (see Article 9.10). Where no agreement exists between formal communityleadership and customary authority regarding the conduct of the proposed research,researchers should inform the REB. When alternative community engagementprocesses are followed to endorse a project, all other ethical safeguards set out inthis chapter remain applicable.

Recognizing Diverse Interests within Communities

Article 9.6 In engaging territorial or organizational communities, researchers should ensure,to the extent possible, that they take into consideration the views of all relevantsectors – including individuals and subgroups who may not have a voice in theformal leadership. Groups or individuals whose circumstances make themvulnerable may need or desire special measures to ensure their safety in the contextof a specific research project. Those who have been excluded from participation inthe past may need special measures to ensure their inclusion in research.

Application Groups or individuals whose circumstances may make them vulnerable ormarginalized within territorial or organizational communities should not bedeprived of opportunities to participate in, and influence, research affecting theirwelfare. For example, people living with HIV/AIDS, impoverished youth orwomen who have suffered abuse may experience barriers to participation.

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Gender-based analysis is being applied in First Nations, Inuit and Métisorganizations and communities to promote or restore recognition of women’sresponsibilities in the conduct of community life – including decision making thatdirectly affects their welfare. The legacy of patriarchal governance structurescontinues to pose challenges to women’s full participation. Approaches that areattentive to cultural considerations help to ensure the equitable participation andbenefit of women throughout the life cycle of a research project (see Article 4.2).

Research undertaken secretly or as a direct challenge to legitimate authority mayincrease risks to participants whose circumstances make them vulnerable, maydeepen rifts within the community, and actually impede the advancement of socialjustice. Strategies that have proven effective to secure the inclusion and promotethe safety of diverse sectors within a community include: advocacy by moralauthorities in the community; special measures to protect the identity of participantsin small communities; identifying research questions that include rather than divideinterest groups; or expanding the coverage of a project to multiple communities.In some cases, the risks to participants and communities involved with, or affectedby, the proposed research outweigh the potential benefits likely to be gained, andthe research should not be undertaken.

Critical Inquiry

Article 9.7 Research involving Aboriginal peoples that critically examines the conduct ofpublic institutions, First Nations, Inuit and Métis governments, institutions ororganizations or persons exercising authority over First Nations, Inuit or Métisindividuals may be conducted ethically, notwithstanding the usual requirement ofengaging community leaders.

Application Considerations in conducting critical inquiry are discussed more fully in Article3.6. As in the case of research involving groups whose circumstances make themvulnerable, or communities of interest within an Aboriginal community (see Article9.6), researchers undertaking critical inquiry research will need to adopt appropriateapproaches to ensure that cultural norms are respected, that the safety of participantsis protected, and that potential harms to the welfare of the larger community areminimized to the extent possible. Researchers may need to consult culturallyrelevant regional or national Aboriginal organizations for guidance.

For example, the Sisters in Spirit project of the Native Women’s Association ofCanada (NWAC) that was launched in 2005 for a five-year period illustratesresearch of a national scope that incorporated a critical dimension. The projectinvolved interviewing families of missing and murdered First Nations, Métis orInuit women in urban and rural settings, and on First Nations territory. It examined,among other matters, the adequacy of public institutions and services, Aboriginaland non-Aboriginal, to protect the women’s well-being and support families in theirefforts to deal with their losses. The objective was to effect policy change andimprove the safety and well-being of Aboriginal women in Canada. NWAC has

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published its commitment to participatory research and the principles and practicesthat protect the privacy and well-being of participants. The project built on NWAC’songoing efforts to develop meaningful research relationships reflecting Aboriginalways of knowing.

Respect for Community Customs and Codes of Practice

Article 9.8 Researchers have an obligation to become informed about, and to respect, therelevant customs and codes of research practice that apply in the particularcommunity or communities affected by their research. Inconsistencies betweencommunity custom and this Policy should be identified and addressed in advanceof initiating the research, or as they arise.

Application First Nations, Inuit and Métis codes of research practice derive from proceduresand customs of predominantly oral cultures. While some rules may be in writtenform, their interpretation is dependent on experiential knowledge acquired throughinteractions in the community. An example is the strict limitation on makingpublicly available sacred knowledge that might be revealed within a trustingrelationship. In academic culture, rules regarding limits on disclosure ofinformation would reasonably be incorporated into a research proposal, and shouldbe integrated into research agreements between communities and researchers wheresuch exists.

The absence, or perceived absence, of a formal local research code or guidelinesdoes not relieve the researcher of the obligation to seek community engagement inorder to identify local customs and codes of research practice.

First Nation, Inuit and Métis customs and codes of behaviour distinguish amongknowledge that can be publicly disclosed, disclosed to a specific audience, ordisclosed under certain conditions. Determination of what information may beshared, and with whom, will depend on the culture of the community involved.Any restrictions on access to, or use of, traditional or sacred knowledge shared inthe course of the research project should be addressed in the research agreement.

In Aboriginal communities, custom may restrict the observation, recording, orreporting of ceremonies or certain performances, and require approval ofappropriate individuals. Article 10.3 addresses the requirement for ethics reviewof research involving observational studies, and associated ethical implications,which may include infringement on consent and privacy.

Many First Nations communities across Canada have adopted an ethics codeoriginally developed to govern practice in the First Nations Regional LongitudinalHealth Survey. The code asserts ownership of, control of, access to, and possession(OCAP) of research processes affecting participant communities, and the resultingdata. OCAP addresses issues of privacy, intellectual property, data custody andsecondary use of data, which are also covered later in this chapter.

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Inuit communities and organizations are considering addressing similar concerns,including adoption or adaptation of OCAP. For example, possession agreements,which are distinct from research agreements, are set out in a memorandum ofunderstanding between the institution of the researcher and the community (usuallyrepresented by the land claim organization). The possession agreement covers thecontrol and use of data and human biological materials collected over the course ofthe research. The agreement may continue to exist long after the research iscompleted, to allow control and use of data and human biological materials for Inuit-initiated research.

Researchers should consult their own institutions to ensure that the application ofOCAP or other community-based ethics codes is consistent with institutionalpolicies. Where divergences exist, they should be addressed and resolved prior tothe commencement of the research, or as they arise over the course of the research.

First Nations, Inuit and Métis scholars attached to academic institutions as facultymembers, students or research associates are increasingly engaged in researchinvolving their own communities, and sometimes their own family members. Theyare generally exempt from restrictions on physical access to territory or personalaccess to community members. However, as members of institutions that adhereto this Policy, they are subject to the ethical duty to respect community customsand codes of research practice when conducting research in their own local orcultural communities, and to engage the relevant community as required by thisPolicy. In these cases, institutional REBs may be concerned about researchers beingin a conflict of interest and should manage the conflict of interest in accordancewith Articles 7.2 and 7.4.

Life history and language research are examples of research areas where insiderrelationships and cultural competencies provide unique opportunities to extend theboundaries of knowledge. Although it can be argued that recording the life historyof an elderly relative is a family matter rather than a community matter, whenundertaken as research, community engagement is important to ensure that thefollowing considerations are reviewed: the potential impact of such research on thewider community; conflicts between the individualist norms of the academicenvironment and the norms of the community; and the possibility of unclear ormistaken assumptions on the part of participant and researcher. During the consentprocess, researchers should give the participant the opportunity to identify therelevant form of community engagement, and at what stage such engagementshould occur. This may include engaging with extended family members, peers ofthe participant with whom the researcher’s interpretations can be validated, orElders knowledgeable about cultural rules governing disclosure of privilegedinformation.

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Institutional Research Ethics Review Required

Article 9.9 Research ethics review by community REBs or other responsible bodies at theresearch site will not be a substitute for research ethics review by institutionalREBs, and will not exempt researchers affiliated with an institution from seekingREB approval at their institution, subject to Article 8.1. Prospective research andsecondary use of data and human biological materials for research purposes issubject to research ethics review.

Application Applying this Policy in a way that accommodates the diversity of First Nations,Inuit and Métis cultures, and mixed Aboriginal communities in urban centres iscomplex. For example, the fit between institutional policies and communitycustoms and codes of research practice may be unclear, requiring researchers toadapt conventional practice or negotiate a resolution.

Consistent with Article 8.3(b), research conducted outside the jurisdiction of theresearcher’s institution shall undergo prior research ethics review by both “(i) theREB at the Canadian institution under the auspices of which the research is beingconducted, and (ii) the REB or other responsible review body or bodies, if any, atthe research site.”

Article 8.1 permits review models for multi-site research that do not requireseparate research ethics review by each site involved in a research project. In caseswhere the community is the direct recipient of funding and has constituted a localREB that is party to an agreement with the researcher’s institution, review by theinstitution’s REB may not be required.

In accordance with Article 8.4, communication between the institutional REB andthe responsible agency in the community may assist in resolving inconsistenciesbetween institutional policy and community customs and codes of research practice.Where a community research ethics review is required in addition to the mandatoryinstitutional REB review, reconciling differences may require resubmission to oneor both review bodies.

Researchers and REBs should recognize that research ethics review by communitybodies will often pursue purposes and apply criteria that differ from the provisionsof this Policy. The express purpose of most Aboriginal community codes ofresearch practice is to ensure the relevance of research undertakings to communityneeds and priorities, and respect for First Nations, Inuit and Métis identities,cultures and knowledge systems. While community codes of practice and researchagreements typically share many of the goals of institutional policies, theapproaches to achieving those goals may differ significantly. It is thereforeinappropriate to insist on uniformity between community practices and institutionalpolicies. For example, when researchers seek to interview Elders willing to share

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their knowledge according to traditional customs of consent, REBs should notimpose language and processes that may be experienced as culturally inappropriateor awkward (see Article 3.12).

In cases where REB review of research on topics related to Aboriginal peoples oraffecting Aboriginal communities is regularly required, the REB membershipshould be modified to ensure that relevant and competent knowledge and expertisein Aboriginal cultures are available within its regular complement. Aboriginalscholars or members drawn from First Nations, Inuit or Métis communities mayfill this role (see Article 6.4). For occasional review of Aboriginal research that islikely to affect the welfare of a community or communities, consultation with adhoc advisors or delegation to a specialized or multi-institutional REB may beappropriate (see Articles 6.5 and Article 8.1).

The membership of community review bodies of First Nations, Inuit or Métiscommunities will not necessarily duplicate the membership criteria set out in thisPolicy. In the context of scarce resources in community organizations, the samepersonnel may be involved in reviewing the ethics of a proposal and co-managingthe research project. An expectation that conflicts of interest will be managed byseparating research ethics review and project management functions may imposeunsupportable demands on small communities. In these circumstances, researchersand participating Aboriginal communities should address the ethical safeguards ofthe community and its members that can be best achieved in circumstances whenmultiple roles are assumed by the same person (see Chapter 7 and, in particular,Article 7.2).

Requirement to Advise the REB on a Plan for Community Engagement

Article 9.10 When proposing research expected to involve First Nations, Inuit or Métisparticipants, researchers shall advise their REB how they have engaged, or intendto engage, the relevant community. Alternatively, researchers may seek REBapproval for an exception to the requirement for community engagement, on thebasis of an acceptable rationale.

Application In order for REBs to consider whether the form of community engagement chosenby the researcher is appropriate, they will require evidence in the form of one ormore of the following: (a) a preliminary or formal research agreement between theresearcher and the responsible body at the research site; (b) a written decision ordocumentation of an oral decision taken in a group setting to approve the proposedresearch or to decline further participation; and (c) a written summary of advicereceived from a culturally informed advisory group or ad hoc committee (e.g., anurban community of interest). Where community engagement is not beingproposed, perhaps due to the nature of the research and the community context (seeArticles 9.1 and 9.2), researchers shall provide a rationale acceptable to the REB.

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Provision of a research agreement is particularly emphasized in health researchfunded by CIHR (see CIHR Guidelines for Health Research Involving AboriginalPeople in References at end of this chapter).

Where a researcher has an ongoing relationship with a community, a letter fromformal or customary leaders in the relevant community may signal approval, andsuffice to proceed with the research.

Where, under the provisions of Articles 6.11 and 10.1, a community signals duringpreliminary discussions with researchers, prior to REB review, that the researchmay proceed but that it does not want further community engagement, researchersshall document and present to the REB the steps they took to invite and facilitateengagement by the community. See Article 9.14 on how researchers may assist incapacity building.

Although researchers shall offer the option of engagement, a community maychoose to engage nominally or not at all, despite being willing to allow the researchto proceed. A community may, for example, support a research project carried outindependent of community influence, or without any further collaboration of thecommunity in the actual implementation of the research in order to use scientificallydefensible results to validate a negotiating position.

Research Agreements

Article 9.11 Where a community has formally engaged with a researcher or research teamthrough a designated representative, the terms and undertakings of both theresearcher and the community should be set out in a research agreement beforeparticipants are recruited.

Application Research agreements serve as a primary means of clarifying and confirming mutualexpectations and, where appropriate, commitments between researchers andcommunities. Research agreements, where applicable, shall precede recruitment ofindividual participants and collection of, or access to, research data. The scope ofthe agreement will depend on the level of engagement which the community desires,and the availability of resources to support community participation.

At a minimum, the agreement should address the ethical protections that wouldapply to securing individual consent for a comparable project, and should specifyany commitments regarding collective community participation and decisionmaking, sharing of benefits and review, and updating of the agreement. Expandingon information normally provided to an individual participant (see Article 3.2),agreements typically set out the purpose of the research and detail mutualresponsibilities in project design, data collection and management (see Article 5.3);analysis and interpretation; credit due to knowledge holders; protection (and non-disclosure) of restricted knowledge; sharing of benefits or royalties flowing fromintellectual property where applicable; production of reports; co-authorship;

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dissemination of results; and a conflict resolution process. Provisions for anyanticipated secondary use of the information or human biological material, andassociated data collected, should also be addressed at that time, and documented inthe research agreement (see Article 9.20).

Where a community has adopted or adheres to a code of research practice, theagreement may set out responsibilities in accordance with that code and the specificrequirements of the research project. In less formal circumstances, the agreementmay be relatively brief, and subject to clarification as the project unfolds. The CIHRGuidelines for Health Research Involving Aboriginal People (2007) provideexamples of elements that may be included in research agreements (see Referencesat the end of this chapter).

Research agreements are increasingly being recognized by academic institutions(and the researchers associated with them) as providing reference points for researchethics review process and approval on such elements as consent, confidentiality,and access to and use of information. Agreements that specify procedures forcommunity research ethics review, included as part of the institutional ethicsapplication, can provide contextual information and guidance for REBs conductinginitial review of applications, and continuing research ethics review throughout theproject. Researchers should check with their institutions regarding signing authorityfor research agreements (see Article 9.18).

Building relationships, clarifying the goals of a project, and negotiating agreementsrequires substantial investment of time and resources on the part of the communityand the researcher. Development and participation costs incurred by the communityand the researcher should be factored into proposals to the extent possible withinfunding guidelines.

Community agreement that a research project may proceed is not a substitute forsecuring the consent of individuals recruited to participate in that project, inaccordance with Chapter 3. Consent of prospective participants shall precedecollection of, or access to, data or human biological materials. Consistent with theprovisions of Article 3.12, if signed written consent is not culturally appropriate,the researcher shall inform the REB of alternative processes employed for seekingand documenting consent.

Consent shall be given in accordance with the research agreement where one exists.Where research agreements provide that community partners will have limited orfull access to identifiable personal data, the consent of participants to this disclosureshall form part of the consent process. Access to confidential information providedby an individual is subject to privacy law.

Researchers should be aware of the first language of Aboriginal participants and, ifan Aboriginal language, researchers should make available translation by aknowledgeable person during the consent process, and during the conduct of

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research in accordance with the wishes of the participant (see Article 4.1).Researchers should be aware of the official status of Inuit languages in Inuit regions.

Collaborative Research

Article 9.12 As part of the community engagement process, researchers and communities shouldconsider applying a collaborative and participatory approach as appropriate to thenature of the research, and the level of ongoing engagement desired by thecommunity.

Application While community engagement is appropriate in any research that affects Aboriginalcommunities, the nature and degree of collaboration between the researcher andthe community will depend on the nature of the research, and the communitycontext. Collaborative approaches in research with Aboriginal communities are ameans of facilitating mutually respectful and productive relations (see Article 9.2).

Collaborative research is generally understood to involve respectful relationshipsamong colleagues, each bringing distinct expertise to a project. Collaboration ofteninvolves one or another of the partners taking primary responsibility for certainaspects of the research, such as addressing sensitive issues in community relations,or scientific analysis and interpretation of data.

In general, community-based research takes place at community sites. Some formsof research are community-centred in that the research focuses not only onindividuals but on the community itself, and may become a project conducted by,for and with the community.

Participatory research is a systematic inquiry that includes the active involvementof those who are the subject of the research. Participatory research is usually action-oriented, where those involved in the research process collaborate to define theresearch project, collect and analyze the data, produce a final product and act onthe results. It is based on respect, relevance, reciprocity and mutual responsibility.

Where participatory research is adopted, the terms and conditions should be set outin a research agreement (see Article 9.11).

Mutual Benefits in Research

Article 9.13 Where the form of community engagement and the nature of the research make itpossible, research should be relevant to community needs and priorities. Theresearch should benefit the participating community (e.g., training, local hiring,recognition of contributors, return of results), as well as extend the boundaries ofknowledge.

Application To benefit the participating community, a research project should be relevant tocommunity priorities and have the potential to produce valued outcomes from theperspective of the community and its members.

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Relevance and community benefit can take a number of forms depending on thetype of research being conducted, and the forms of community engagement. Forexample, genetic research on diabetes in a First Nations community is unlikely tobenefit the community in the short term, but collaboration may facilitate increasedknowledge of the condition, and what changes can be made to improve healthoutcomes. Collaborative research can thus accommodate basic, as well as applied,research, and include short-term and long-term benefits. In another example, acommunity invites a researcher to collaborate in a research project about housingand homelessness in an Inuit community. Using participatory research methodsand social science tools, the nature, extent and consequences of the local housingshortage are documented, enabling the community to effectively communicate itsneeds to non-Inuit (Qallunaat) authorities. Other benefits include trainingworkshops that provide employment and transfer skills to Inuit youth involved indata collection, field experience in community-based research for university studentassistants and materials useful to other Inuit communities in subsequent research.

Collaborative research approaches provide the community with the opportunity todiscuss risks and potential benefits, and to minimize risks. Where participatoryresearch is undertaken, the research report might also formulate recommendationson how to implement interventions resulting from the research for the benefit ofthe participating community.

A possible outcome of collaborative research, and in particular participatoryresearch, is increased capacity to carry out research that can more readily beconducted in Aboriginal languages and oral modes. The exploration, articulationand application of knowledge specific to a community or communities are thusadvanced, potentially benefiting other First Nations, Inuit or Métis communitiesthrough knowledge transfer.

Researchers should provide communities access to research data that will allowthem to address pressing issues through community-generated policies, programs,and services (see Article 9.8 and the Application of Article 9.11). Territorial andorganizational communities and communities of interest may also seek to share inthe benefits of research activities, which may include direct research grants, releasetime for project personnel, overhead levies on shared projects and commercializa-tion of research discoveries.

Strengthening Research Capacity

Article 9.14 Research projects should support capacity building through enhancement of theskills of community personnel in research methods, project management, andethical review and oversight.

Application Collaborative research approaches provide for reciprocal learning and for transferof skills and knowledge between the community and the researcher. Researchersshould foster education and training of community members to enhance their

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participation in research projects. Employing Aboriginal research assistants andtranslators is already common practice in community-based projects. Extendingskills transfer through a program of training will support collaboration withinstitutions, and advance the capacity of communities to initiate and implementtheir own research. Collaborative research can also support building capacity ofthe research community to conduct culturally relevant research.

Lack of engagement by communities may be due to inadequate financial or humanresources. Communities vary widely in the level of human and material resourcesthey have available to collaborate with research initiatives. Structural barriers mayprevent access to, and participation in, research. For example, small, remotecommunities and many urban communities of interest have limited organizationalresources to advise or collaborate in research. The least organizationally developedcommunities are the most vulnerable to exploitation. Research undertaken in thesecircumstances should strive to enhance capacity for participation.

Funding programs that target the development of Aboriginal research and capacitybuilding seek to generate significant research training opportunities. Fundingcriteria allow researchers to include in their grant applications stipends forundergraduate, master’s or doctoral students, or post-doctoral researchers, asappropriate, with priority given to Aboriginal candidates. The time required toestablish collaborative relationships may be difficult to accommodate in theprograms of students. Mentorship by experienced researchers who introducestudents to communities and monitor their ethical practice can facilitate the trust-building process and advance student progress.

Recognition of the Role of Elders and Other Knowledge Holders

Article 9.15 Researchers should engage the community in identifying Elders or other recognizedknowledge holders to participate in the design and execution of research, and theinterpretation of findings in the context of cultural norms and traditional knowledge.Community advice should also be sought to determine appropriate recognition forthe unique advisory role fulfilled by these persons.

Application Within First Nations, Inuit and Métis communities, persons with special gifts carryvaried roles and responsibilities in conserving and transmitting traditionalknowledge and expressions of culture. They often are fluent in their traditionallanguage. They model respectful relationships and may conduct ceremonies, passon oral history, and offer guidance in community affairs. Their gifts are normallyrefined over a lifetime. Thus, Elders who have followed a rigorous path of learningover a long period are highly respected. Younger persons may also gain recognitionas gifted knowledge holders.

High regard by the community that knows the Elder or other knowledge holder isthe most reliable indicator of an individual’s authority. Each community or nationhas particular ways of approaching Elders or knowledge holders respectfully. In

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many First Nations this involves the presentation and acceptance of tobacco tosymbolize entering into a relationship. In some communities, feasting or gift-givingis appropriate.

Elders are now being recognized in research proposals and grant applications asproviders of access to community networks, ethical guidance to researchers, andadvice in interpreting findings in the context of traditional knowledge (see Article9.17). Researchers should seek advice from the community and the Elders regardingthe appropriate recognition of the contribution of Elders and knowledge holders,which may include providing honoraria, acknowledging contributions by name or,as directed, withholding the Elder’s identity in reports and publications.

Privacy and Confidentiality

Article 9.16 Researchers and community partners shall address privacy and confidentiality forcommunities and individuals early on in the community engagement process. Theextent to which limited or full disclosure of personal information related to theresearch is to be disclosed to community partners shall be addressed in researchagreements where these exist. Researchers shall not disclose personal informationto community partners without the participant’s consent, as set out in Article 3.2(i).

Application Researchers and community partners should consider early in the design of theresearch how community codes of research practice fit with provisions for privacyand confidentiality as set out in Chapter 5. Where inconsistencies exist, they shouldbe resolved in advance of starting the research. The research agreement shouldaddress how inconsistencies will be addressed if they arise over the course of theconduct of the research project.

In First Nations communities, privacy and confidentiality of identifiable personaland community information may be affected by the application of the principlesof ownership, control, access and possession (OCAP – see definition in Applicationof Article 9.8). The First Nations Regional Longitudinal Health Survey adminis-tered by regional First Nations organizations has addressed balancingconfidentiality and access by having communities designate a regional organizationto hold data, while local authorities make decisions on who can access the data,and under what conditions. In practice, the organization that serves as data stewardevaluates requests for information, and its recommendations to community author-ities have considerable influence.

Whatever the nature of the research, it shall be designed to include safeguards forparticipant privacy and measures to protect the confidentiality of any data collected.Small Aboriginal communities are characterized by dense networks ofrelationships. As a result, coding individual data is often not sufficient to maskidentities, even when data are aggregated. Some Aboriginal participants arereluctant to speak to interviewers from their own community because of privacy

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concerns. Communities themselves have distinguishing characteristics, which insome cases have compromised efforts to disguise the research site, and has led tothe stigmatization of entire communities.

On the other hand, in some social sciences and humanities research, the significanceof information is tied to the identity of the source. In these cases individualattribution, with consent, is appropriate. When individual participants waiveanonymity, researchers should ensure that this is documented (see Application ofArticle 5.1 and Article 9.11). Communities partnering in research may wish to beacknowledged (e.g., in the research report) for their contribution to the researcheffort.

Research undertaken with participants who have suffered traumatic experiences(e.g., former residential school students) poses a risk of re-traumatizing participants.Researchers should anticipate such risks in the research design, and adhere tocultural protocols for determining participant needs and access to traumacounselling.

Privacy protections in research are evolving. Respect for, and accommodation of,First Nations, Inuit and Métis priorities on joint ownership of the products ofresearch and maintaining access to data for community use should guide researchpractices – with appropriate deference to applicable federal, provincial andterritorial privacy legislation.

Interpretation and Dissemination of Research Results

Article 9.17 Researchers should afford community representatives engaged in collaborativeresearch an opportunity to participate in the interpretation of the data and the reviewof research findings before the completion of the final report, and before finalizingall relevant publications resulting from the research.

Application Where collaborative approaches are followed, researchers should ensure continuingcommunications with the participating community. Territorial or organizationalcommunities or communities of interest engaged in collaborative research mayconsider that their review and approval of reports and academic publications isessential to validate findings, correct any cultural inaccuracies, and maintain respectfor community knowledge (which may entail limitations on its disclosure).Researchers should integrate suggestions from the community representatives inthe publication. If disagreement about interpretation arises between researchers andthe community and it cannot be resolved, researchers should either (a) provide thecommunity with an opportunity to make its views known, or (b) accurately reportany disagreement about the interpretation of the data in their reports or publications.This should not be construed as giving the community the right to block thepublication of findings. Rather, it gives the community the opportunity tocontextualize the findings.

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Final reports shall be made available to the territorial or organizational communityor community of interest participating in the research. Researchers andcommunities should clarify the extent to which research findings will requiretranslation, plain language summaries or oral presentations to community members,in order to make the research findings accessible to the community.

An Aboriginal community, and those who participated in the research, should havethe option to participate in deciding how collective or individual contributions tothe research project will be acknowledged and credited in the dissemination ofresults (e.g., acknowledgement of co-authorship in research reports or atconferences and seminars).

Intellectual Property Related to Research

Article 9.18 In collaborative research, intellectual property rights should be discussed byresearchers, communities and institutions. The assignment of rights, or the grantof licences and interests in material that may flow from the research, should bespecified in a research agreement (as appropriate) before the research is conducted.

Application Researchers, communities and institutions should be aware that all knowledge andinformation is not necessarily protected under the existing law. Existing intellectualproperty legislation generally protects works and inventions. Strict criteria are usedto define intellectual property rights. Understanding and communicating whatqualifies, or does not qualify, as intellectual property for the purposes of researchunder this Policy is a joint responsibility of communities, researchers andinstitutions.

When undertaking research guided by community engagement, researchers,institutions and communities may need to first address issues regarding access todata, and the use of data for the purpose of the research or in the dissemination ofresearch findings. Regarding access to and use of data, a research agreement mayset out any limits on the disclosure of personal or privileged information (subjectto applicable legal and regulatory requirements and the guidance in Chapter 5 ofthis Policy). It might include provisions to review reports and publicationsregarding the research prior to publication, or limits on the release of, or access to,research results (subject to applicable laws). Provisions for any anticipatedsecondary use of the information or human biological material, and associated datacollected, should also be addressed and documented in this agreement. It may alsoset out any interests, licences or assignments in copyright flowing from publicationsabout, or based on, the research (see Articles 9.8, 9.11 and 9.16).

Some knowledge collected as a result of the research may have commercialapplications, and lead to the development of marketable products. With respect tocommercialization of results of collaborative research, researchers and communitiesshould discuss and agree on the use, assignment or licensing of any intellectualproperty (e.g., any patents or copyright), resulting from the marketable product,

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and document mutual understandings in an agreement. If the proposed researchhas explicit commercial objectives, or direct or indirect links to the commercialsector, researchers and communities may want to include provisions related toanticipated commercial use in research agreements. These provisions should beclearly communicated to all parties in advance, consistent with the consent process.

Researchers should consult the research office of their institution before enteringinto a research agreement that includes intellectual property provisions. Researchersshould also consult the program literature or policies on intellectual property andcopyright adopted by the federal research agencies CIHR, NSERC and SSHRC(available on their websites), and seek legal advice where appropriate.

Collection of Human Biological Materials Involving Aboriginal Peoples

Article 9.19 As part of community engagement, researchers shall address and specify in theresearch agreement the rights and proprietary interests of individuals andcommunities, to the extent such exist, in human biological materials and associateddata to be collected, stored and used in the course of the research.

Application Canadian law does not provide clear recognition of property rights in humanbiological materials. Researchers should be aware, however, that Aboriginal peopleand communities may seek to maintain control over, and access to, data and humanbiological materials collected for research. This is in accordance with Aboriginalworld views about “full embodiment,” in which every part and product of thehuman body is sacred and cannot be alienated. Consistent with Articles 9.8 and9.11 and Chapter 12, researchers and communities should address and specify inthe research agreement:

• the objectives for collection, use and storage of human biological materials;

• the roles and responsibilities regarding custodianship of the data and the humanbiological materials; and

• any future use of these human biological materials and associated data,including material transfer agreements to third parties, and any subsequentrequirements for community engagement.

Researchers must seek consent, in accordance with Articles 12.1 and 12.2, fromindividuals who are invited to donate their biological materials.

Secondary Use of Information or Human Biological Materials Identifiable as Originating from Aboriginal Communities or Peoples

Ongoing sensitivity about secondary use of data collected for approved purposes arises fromexperiences with misrepresentation of Aboriginal peoples; use of data or human biologicalmaterials without appropriate engagement with the source community or consent of participants;and lack of reporting to communities on research outcomes. For example, members of Nuu-chah-nulth communities in British Columbia provided blood samples for research on rheumatic disease.

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They vigorously protested the use of their blood components for subsequent unauthorized geneticresearch. In addition, there are fears in First Nations communities that access to health data forpurposes other than treatment will facilitate unauthorized government surveillance.

When seeking to undertake research involving secondary use of data identifiable as originating froma specific Aboriginal community or segment of the Aboriginal community at large, researchers shall,through community engagement as appropriate, address any potential inadvertent identification ofcommunities, or misuse of traditional knowledge. Requirements regarding the participant’s consentfor secondary use of identifiable information are addressed in Articles 9.20 and 9.21.

Article 9.20 Secondary use of data and human biological material identifiable as originatingfrom an Aboriginal community or peoples is subject to REB review.

Researchers shall engage the community from which the data or human biologicalmaterials and associated identifiable information originate, prior to initiatingsecondary use where:

(a) secondary use has not been addressed in a research agreement and has not beenauthorized by the participants in their original individual consent; or

(b) there is no research agreement; and

(c) the data are not publicly available or legally accessible.

Individual consent for the secondary use of identifiable information is requiredunless the REB agrees that either Articles 5.5A or 5.6, or Articles 12.3A or 12.4 mayapply.

Application Where the researcher can satisfy the REB that secondary use is consistent with anexisting research agreement, the REB may require that the researcher engage thecommunity from which the data or human biological materials and associatedidentifiable information originate – in accordance with the terms of the researchagreement. New consent from individuals for secondary use is not required wherethe proposed secondary use is authorized by the REB in accordance with thisPolicy.

Article 9.21 Where research relies only on publicly available information, or on legallyaccessible information as defined in Article 2.2, community engagement is notrequired. Where the information can be identified as originating from a specificcommunity or a segment of the Aboriginal community at large, seeking culturallyinformed advice may assist in identifying risks and potential benefits for the sourcecommunity.

Application Research based only on publicly available information or legally accessibleinformation as defined by this Policy, does not involve the collection of data fromcommunities directly, or from living persons. As indicated in Chapter 2, REBreview for this type of research is not required. Community engagement is notrequired. Examples are historical or genealogical research or statistical analysis.

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In these cases, researchers may not have any direct relationship with communitiesbut their findings may, nevertheless, have an impact on the identity or heritage ofpersons or communities. In order to minimize any harm, researchers should seekculturally informed advice before the use of such data to determine if harms mayresult and if other considerations, such as sharing of the research results, should beexplored with the original source community (see Article 9.15).

Where access to publicly available information or legally accessible informationleads to new research initiatives to collect additional information from identifiedcommunities or individuals, REB review is required. The provisions set out inArticle 5.6 apply for new initiatives of this kind.

Article 9.22 REB review is required where the researcher seeks data linkage of two or moreanonymous datasets or data associated with human biological materials and thereis a reasonable prospect that this could generate information identifiable asoriginating from a specific Aboriginal community or a segment of the Aboriginalcommunity at large.

Application The REB may determine that community engagement is required to seek guidanceon secondary use. Articles 5.5A and 5.6 or Articles 12.3A and 12.4 may apply.

Consistent with Article 2.4, REB review is not required for research involving onlyanonymous datasets or anonymous human biological materials, and associated data,that cannot be identified as originating from a specific Aboriginal community or asegment of the Aboriginal community at large. Community engagement is notpossible given that the data or human biological materials cannot be linked to aspecific Aboriginal community or specific individuals. Where the researcher seeksdata linkage of two or more anonymous sets of information or human biologicalmaterials and there is a reasonable prospect that this could generate identifiableinformation, then REB review is required.

Endnotes

1 Indian peoples commonly identify themselves as “First Nations.” First Nation: A term that came intocommon usage in the 1970s to replace the word “Indian,” which some people found offensive. Althoughthe term First Nation is widely used, no legal definition of it exists. Among its uses, the term “FirstNations peoples” refers to the Indian peoples in Canada, both Status and non-Status. Some Indianpeoples have also adopted the term “First Nation” to replace the word “band” in the name of theircommunity. 2 Constitution Act, 1982, s. 35.

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References

• Canadian Institutes of Health Research. CIHR Guidelines for Health Research InvolvingAboriginal People. May 2007.

• ———. CIHR Best Practices for Protecting Privacy in Health Research. September 2005.

• First Nations Centre. OCAP: Ownership, Control, Access and Possession. Sanctioned by theFirst Nations Information Governance Committee, Assembly of First Nations. Ottawa: NationalAboriginal Health Organization.

• First Nations Regional Longitudinal Health Survey (RHS).

• Interagency Advisory Panel on Research Ethics. Aboriginal Research Ethics Initiative. “Issuesand Options for Revisions to the Tri-Council Policy Statement: Ethical Conduct of ResearchInvolving Humans (TCPS): Section 6: Research Involving Aboriginal Peoples.” February 2008.

• Inuit Tapiriit Kanatami (ITK) and Nunavut Research Institute (NRI). Negotiating ResearchRelationships with Inuit Communities: A Guide for Researchers. Edited by Scot Nickels, JamalShirley and Gita Laidler. ITK and NRI: Ottawa and Iqaluit.

• Nipingit: National Inuit Committee on Ethics and Research, a joint program of the InuitTuttarvingat the National Aboriginal Health Organization and Inuit Tapiriit Kanatami, Researchand Research Ethics Fact Sheets.

• Royal Commission on Aboriginal Peoples. Report of the Royal Commission on AboriginalPeoples. “Ethical Guidelines for Research.” In Volume 5, Renewal: A Twenty-YearCommitment, Ottawa: Canada Communications Group. 1996.

• United Nations Educational, Scientific and Cultural Organization. Universal Declaration onBioethics and Human Rights. Adopted October 19, 2005, by the 33rd session of the GeneralConference of UNESCO. 2005.

• United Nations. Convention on Biological Diversity. 1992.

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Chapter 10QUALITATIVE RESEARCH

Introduction

Researchers in social sciences and humanities – such as anthropology, sociology, philosophy,psychology, criminology, business administration, political science, communications, educationand history – have a common belief in the desirability of trying to understand human action throughsystematic study and analysis. Some researchers use quantitative research approaches, others optfor qualitative research methods, and some use a combination of both.Qualitative research has a long history in many established disciplines in the social sciences andhumanities, as well as many areas in the health sciences (e.g., nursing, occupational therapy). Theuse of qualitative approaches is increasing, whether in health research or in social sciences andhumanities disciplines. Within specific disciplines, ethics guidelines have been created to addressthe issues inherent in the use of, for example, particular methods, technologies and settings.Qualitative research approaches are inherently dynamic and may be grounded in differentassumptions than those that shape quantitative research approaches. Many of the research practicesand methodological requirements that characterize qualitative research approaches parallel thosethat characterize quantitative approaches such as concerns regarding research quality. However,as is the case with all research involving humans, the criteria are adapted to the specific subjectmatter, context and epistemological assumptions about the nature of knowledge in the specificarea of research of the specific project.

This chapter seeks to provide specific guidance on some issues that are particularly germane toqualitative research, although such guidance may also be applicable to research using quantitativeor mixed methods. In particular, it addresses issues of consent, privacy and confidentiality thatmay have unique manifestations in qualitative research. Some procedural issues related to thedynamics and characteristics of qualitative research that affect the timing and scope of the researchethics review process are detailed below. Note that subject to applicable laws, the articles in thisPolicy relating to consent, privacy and confidentiality equally apply in the context of qualitativeresearch.

Researchers and research ethics boards (REBs) should also consult other relevant chapters of thePolicy for additional guidance on principles, norms, and practices applicable to qualitative research.

A. Nature of Qualitative Research

Qualitative research aims to understand how people think about the world and how they act andbehave in it. This approach requires researchers to understand phenomena based on discourse,actions and documents, and how and why individuals interpret and ascribe meaning to what theysay and do, and to other aspects of the world (including other people) they encounter.

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Some qualitative studies extend beyond individuals’ personal experiences to explore interactionsand processes within organizations or other environments. Knowledge at both an individual anda cultural level is treated as socially constructed. This implies that all knowledge is, at least tosome degree, interpretive, and hence, dependent on social context. It is also shaped by the personalperspective of the researcher as an observer and analyst. As a result, qualitative researchers devotea great deal of attention to demonstrating the trustworthiness of their findings using a range ofmethodological strategies.

The section below provides a summary description of the general approach, as well as method-ological requirements and practices, of qualitative research, some of which may also apply toquantitative or other types of research involving humans.

General Approach and Methodological Requirements and Practices

(a) Inductive Understanding: Many forms of qualitative research entail gaining an inductiveunderstanding of the world of participants to acquire an analytic understanding of howthey view their actions and the world around them. In some projects, this approach alsoapplies to the study of particular social settings, processes and experiences.

To the extent that the methods involve direct interaction with participants, there is oftenan emphasis on gaining insights into participants’ perceptions of themselves and others,and of the meanings that participants attach to their thoughts and behaviours.

(b) Diversity of Approaches: There is no single approach in qualitative research. Differentfields or disciplines, and even individual scholars within a discipline, have differentperspectives on, and approaches to, the use of qualitative methods. Qualitative researchuses a variety of theoretical approaches, questions that guide the research, methodologies,epistemological approaches, and techniques that allow researchers to enter the participants’world or to engage with particular social environments. Methodological approachesinclude, but are not limited to, ethnography, participatory action research, oral history,phenomenology, narrative inquiry, grounded theory and discourse analysis. The term“qualitative research” covers a wide range of overlapping paradigms or perspectives.

(c) Dynamic, Reflective and Continuous Research Process: The emergence during thecourse of the research itself of questions, concepts, strategies, theories and ways to gatherand engage with the data (e.g., emergent design research, see Article 10.5) requires aconstant reflective approach and questioning by the researcher. Such flexibility, reflexivityand responsiveness contribute to the overall strength and rigour of data collection andanalysis.

(d) Diverse, Multiple and Often Evolving Contexts: Qualitative research takes place in avariety of contexts, each of which presents unique ethical issues. As knowledge isconsidered to be context-contingent in qualitative research, these studies tend to focus onparticular individuals, sites or concepts that are empirically derived from other socialsettings. The researcher’s priority is to answer the research question stemming from thestudy of those individuals in a specific social setting at a specific time.

Chapter 10 – Qualitative Research

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Researchers sometimes engage in research that questions social structures and activitiesthat create, or result in, inequality and injustice. Studies may involve participants who arein highly vulnerable circumstances because of the social and/or legal stigmatization thatis associated with their activity or identity, and who may have little trust in the law, socialagencies or institutional authorities. Regardless of the methodological approach,researchers who question social structures, or deal with the disempowered, may facepressures from authority figures. Research may also involve participants, such as businessexecutives or government officials, who may be more powerful than the researchers.

(e) Data Collection and Sample Size: There is generally a greater emphasis placed on depthof research than on breadth. Most qualitative researchers would emphasize gatheringdiverse but overlapping data on a limited number of cases or situations to the point of datasaturation or thematic redundancy. Samples and research sites in these studies are chosenbecause they are viewed as particularly useful or rich sources of information for furtheringone’s understanding of phenomena of interest, and not because the results may provestatistically significant. Participants are selected for their potential to inform theorydevelopment, and often selection of participants is guided by emerging patterns over thecourse of the data collection.

A researcher may rely on multiple sources of information and data gathering strategies toenhance data quality. Researchers use a variety of methods for data gathering, includinginterviews, participant observation, focus groups and other techniques. In some cases,gathering of trustworthy data is best achieved by closeness and extended contact withparticipants. In other cases, researchers and participants may continue research exchangesthrough electronic or other means, after collection of data in the field. Qualitative studiesof textual and image-based materials, such as published books, websites, interviewtranscripts, photographic images or video, use a variety of content analysis techniques.

Appropriate treatments of data after they are gathered may vary greatly (see Article 10.5and also Article 5.3). At the time of the initial consent discussion, researchers informprospective participants about the confidentiality of the data and discuss the expectationsof participants (see Articles 3.2 and 5.2).

(f) Research Goals and Objectives: The aims of qualitative research are very diverse, bothwithin and across disciplines. The intended goals of qualitative projects may include“giving voice” to a particular population, engaging in research that is critical of settingsand systems, or the power of those being studied, affecting change in a particular socialenvironment, or exploring previously understudied phenomena to develop new theoreticalapproaches to research.

(g) Dynamic, Negotiated and Ongoing Consent Process: Entry into a particular setting forresearch purposes sometimes requires negotiation with the population of interest;sometimes the researcher cannot ascertain the process in advance of the research, in partbecause the relevant contexts within which the research occurs evolve over time.


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In some cases, participants hold equal or greater power in the researcher-participant rela-tionship, such as in community-based and/or organizational research when a collaborativeprocess is used to define and design the research project and questions, or where partici-pants are public figures or hold other positions of power (e.g., research involving economic,social, political or cultural elites). In other cases, researchers themselves may hold greaterpower when access to prospective participant populations is gained through gatekeeperswith whom the researcher has established a relationship (e.g., when a researcher engageswith the police to do research in relation to a problem population, or when researchers en-gage with prison authorities to do research with offenders).

(h) Research Partnerships: Access to particular settings and populations is sometimesdeveloped over time, and the relationships that are formed may well exist outside theresearch setting per se, which sometimes makes it difficult to determine exactly where the“research” relationship begins and ends. In many cases, despite in-depth, advancepreparation, a researcher may not know until the actual data collecting starts just wherethe search will lead. Indeed, the emergent nature of many qualitative studies makes theachievement of rapport with participants and feelings of interpersonal trust crucial to thegeneration of questions considered important or interesting by both parties, and to thecollection of dependable data. Research often becomes a collaborative process negotiatedbetween the participant(s) and the researcher, requiring considerable time spent initiallysimply figuring out the focus of the research.

In certain cases, contacts between researchers and participants can extend over a lifetime,and these individuals may engage in a variety of relationships over and above their specific“research” relationship.

(i) Research Results: Generalizability of the results to other contexts and the representative-ness of the sample may or may not be a concern in qualitative research. Transferability ofresults from one setting to another is often viewed as more of a theoretical issue than aprocedural or a sampling issue.

B. Research Ethics Review of Qualitative Research

This section provides guidance on issues particularly germane to REB review of researchemploying qualitative methods. Qualitative research is also subject to the general guidelines thatare applicable to research involving humans. The requirement for consent and the protection ofprivacy and confidentiality do not change with the nature of the research.

Qualitative research may pose special ethical issues around gaining access, building rapport, usingdata and publishing results. Researchers and REBs should consider issues of consent,confidentiality and privacy, and relationships between researchers and participants in the design,review and conduct of the research. Some of these may be identified in the design phase. Otherswill arise during the research itself, which will require the exercise of discretion, sound judgmentand flexibility commensurate with the level of risk and potential benefit arising from the research,and considering the welfare of the participants, individually or collectively.


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Timing of the REB Review

Article 10.1 Researchers shall submit their research proposals, including proposals for pilotstudies, for REB review and approval of its ethical acceptability prior to the startof recruitment of participants, or access to data. Subject to the exceptions in Article10.5, REB review is not required for the initial exploratory phase (often involvingcontact with individuals or communities) intended to discuss the feasibility of theresearch, establish research partnerships, or the design of a research proposal (seeArticle 6.11).

Application It is sometimes difficult to ascertain the beginning and end of a qualitative researchproject. Access to particular settings and populations often develops over time, andit is not unusual for researchers to be passive observers, or simply passivelyinterested in a setting for some time, before any formal effort is made to establisha “research” relationship. Preliminary activities may include note taking, diarywriting and observation long before the researcher formalizes a research project.These types of preliminary activities are not subject to REB review (see Article6.11). However, if researchers later wish to use material from this phase, they shallsay so in their research proposal, and include any plan to seek consent from thoseinterviewed in the exploratory phase to use their remarks.

Researchers need to have the opportunity to engage in preliminary visits anddialogue to explore possible research relationships, and to define researchcollaborations with particular settings or communities. Activities may include, butare not limited to, determining research questions, methods, targeted sample andsample size, and addressing community-based concerns in the project design anddata collection. REBs should be aware that dialogue between researchers andcommunities at the outset, and prior to formal REB review, is an integral componentof the research design. Researchers may need to consult the REB informally whenethics issues arise prior to the data collection, or inform the REB of such issuesover the course of the research.

Qualitative research approaches involving a community, group or population ofinterest (e.g., marginalized or privileged groups) usually follow a process of priordialogue, exchanges and negotiation of the research, which precedes the formaldata collection involving participants. In community-based collaborative research,it may be desirable to engage the community before seeking REB review. Forinstance, in research in Aboriginal communities, it may be desirable to obtainpermission to proceed from community leaders, Elders or representatives (seeChapter 9). Similarly, when designing community-based research involvingindividuals whose legal status is compromised, it may be desirable to consult withsocial service providers serving that population.


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Modalities of Expression of Consent

Article 10.2 Researchers shall explain in their research design the proposed procedures forseeking consent and the strategies they plan to use for documenting consent.

Application As part of its research ethics review, REBs should consider the range of strategiesfor documenting the consent process that may be used by researchers usingqualitative research approaches (see Article 3.12). Under a variety of circumstances,signed written consent is not appropriate in qualitative research. However, wherethere are valid reasons for not recording consent through a signed written consentform, the procedures used to seek and confirm consent must be documented.

The consent process should be based on mutual understanding of the project goalsand objectives between the participants and the researcher. The participant mayperceive attempts to legalize or formalize the process as a violation of that trust.Qualitative researchers use a range of procedures to seek and document consent,including oral consent documented in field notes, and other forms of recording (aconsent log, audio or video recordings, or other electronic means) Evidence ofconsent may also be documented via completed questionnaires (in person, by mail,or by email or other electronic means).

REBs may need to consider the power relationship that might exist betweenresearchers and participants, and whether a waiver of the requirement for signedwritten consent may affect the welfare of the participants. In cases where theparticipant holds a position of power, or routinely engages in communicativeinteractions similar to those involved in the research by virtue of their position orprofession (e.g., a communications officer or spokesperson for an organization),consent can be inferred by the participant’s agreeing to interact with the researcherfor the purpose of the research. For example, some political science researchfocuses on power structures and individuals in positions of power (e.g., a seniorpartner in a law firm, a cabinet minister or a senior corporate officer). In this typeof research, where a prospective participant agrees to be interviewed on the basisof sufficient information provided by the researcher, it may be sufficient for theparticipant to signify consent to participate in the research. The researcher shouldrecord this in an appropriate way. Researchers shall demonstrate to the REB thatthe participant will be informed about the research including the option not toparticipate, or to withdraw from the study at any time. Nothing in this article shouldbe interpreted to mean that prospective participants need not be informed about thestudy prior to their participation.

Researchers and REBs should consult Chapter 3, and Articles 3.1, 3.2, 3.3 and 3.12in particular, for additional details and considerations on consent, and how todocument consent.


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Observational Studies

In qualitative research, observation is used to study behaviour in a naturalenvironment. It often takes place in living, natural and complex communities orsettings, in physical environments, or in virtual settings. Observational studies maybe undertaken in publicly accessible spaces (e.g., a stadium, library, museum,planetarium, beach, park), in virtual settings (e.g., Internet chat rooms), or in privateor controlled spaces (e.g., private clubs or organizations).

Observational research is of two kinds: “non-participant” where the researcherobserves, but is not a participant in, the action (also known as “naturalisticobservation”); and “participant” where the researcher engages in, and observes, theaction.

Participant observation is often identified with ethnographic research, in which theresearcher’s role is to gain a holistic overview of the studied context throughengagement in, and observation of, the setting to describe its social environments,processes and relationships. Participant observation may or may not requirepermission to observe and participate in activities of the setting studied. In somesituations, researchers will identify themselves and seek consent from individualsin that setting; in others, researchers will engage in covert non-participant orparticipant observation and not seek consent.

A matter that is publicly accessible may, nevertheless, be considered private in aprospective participant’s culture. There may be a reasonable expectation of privacyby some groups, or for some activities. For example, individuals involved inreligious services or practices, or chat rooms on the Internet, may assume thatparticipants and observers will accord the proceedings some degree of privacy.Observing sacred ceremonies without approval from the appropriate individuals orgroups (e.g., Elders or traditional knowledge holders in Aboriginal research) andwithout engaging them about the subsequent use or interpretation of the data mayhave unintended negative implications (see Articles 9.5, 9.6 and 9.8).Considerations of the nature of the research, its aims and its potential to invadesensitive interests may help researchers improve the design and conduct of suchresearch.

Observational studies in public places where there is no expectation of privacy areexempt from REB review (see Article 2.3).

Article 10.3 In research involving observation in natural environments or virtual settings wherepeople have a reasonable or limited expectation of privacy, the researcher shallexplain the need for an exception to the general requirement for consent. The REBmay approve research without requiring that the researcher obtain consent fromindividuals being observed on the basis of the justification provided by theresearcher and appropriate privacy protection.


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Application Observational studies raise concerns for the privacy of those being observed. Inobservational research, breaches of privacy may arise from identification ofindividuals, groups or communities in the publication or dissemination of researchresults.

Observational research that does not allow for the identification of the participantsin the dissemination of results, that is not staged by the researcher, and is non-intrusive should normally be regarded as being of minimal risk.

REBs and researchers need to consider the methodological requirements of theproposed research project and the ethical implications associated with observationalapproaches, such as the possible infringement of privacy. They should pay closeattention to the ethical implications of such factors as the nature of the activities tobe observed, the environment in which the activities are to be observed, whetherthe activities are staged for the purpose of the research, the expectations of privacythat prospective participants might have, the means of recording the observations,whether the research records or published reports involve identification of theparticipants, and any means by which those participants may give permission tobe identified. REBs shall ensure that the proposal contains measures to protect theprivacy of the individual in accordance with the law.

Researchers and REBs should consult Chapters 3 and 5 for additional details andconsiderations regarding consent, and privacy and confidentiality.

For observational research in which consent is not sought, researchers shalldemonstrate to the REB that necessary precautions and measures have been takento address privacy and confidentiality issues.

Because the knowledge that one is being observed can be expected to influencebehaviour, research involving non-participant or covert observation generallyrequires that the participants not know that they are being observed for researchpurposes. Typically the researcher has no direct interaction with the individualsbeing observed and therefore their consent is not sought. Covert observation ofqueuing behaviours in shopping malls is one example of a study where the researchcould not be completed if shoppers knew that they were being observed. Someforms of qualitative research seek to observe and study criminal behaviours, violentgroups, or groups with restricted membership or access using covert participantobservation. For example, some social science research that critically probes theinner workings of criminal organizations might never be conducted if theparticipants know in advance that they are being observed. Other observationalstudies may be anonymous but involve intervention by the researcher (e.g., studyingthe propensity of bystanders to help in an emergency normally requires a stagedemergency). These methodological approaches may require the researcher seekingan exception to the requirement to seek prior consent.

Where no personal information is collected, consent is not required. Where personalinformation will be collected, researchers must explain whether the need for such


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covert research justifies an exception to the requirement to seek prior consent, andREBs should exercise their judgment taking into consideration the methodologicalrequirements (see Article 3.7A). Researchers and REBs shall take the necessarysteps to ensure that the privacy of the individual is protected in accordance withthe law in the absence of consent. Where no consent is sought, researchers andREBs may also consider whether debriefing is possible, practicable and appropriate(see Article 3.7B). Chapter 5 on privacy and confidentiality provides additionalinformation.

Researchers and REBs should also be aware that, in some jurisdictions, publicationof identifying information – for example, a photograph taken in a public place, butfocused on a private individual who was not expecting this action – may beinterpreted in a civil suit as an invasion of privacy.

Privacy and Confidentiality in the Dissemination of Research Results

Article 10.4 In some research contexts, the researcher may plan to disclose the identity ofparticipants. In such projects, researchers shall discuss with prospective participantsor participants whether they wish to have their identity disclosed in publicationsor other means of dissemination. Where participants consent to have their identitydisclosed, researchers shall record each participant’s consent.

Application In some types of qualitative research (e.g., oral history, a biographical study or astudy involving specific personalities) respect for the participant’s contribution isshown by identifying the individual in research publications, or other means ofdissemination of the results from the research. For instance, in an interview studywith visual artists concerning some aspect of the way they work, it might beappropriate and respectful to identify the respondents. If failing to identifyparticipants would be unethical because of any disrespect it would represent, or ifinformed participants assert their desire to be named, then researchers should doso, according to the practices of their discipline. For example, social historians seekto document and archive the lives of individuals, or highlight the contributions thatordinary people make in social and political life. In oral history, anonymity is theexception. Researchers make the option for anonymity known to participants aspart of the discussion around the nature and conditions of their consent.

In some types of critical inquiry, anonymity would result in individuals in positionsof power not being held accountable for their actions, and for how their exerciseof power has implications for others. The safeguards for those in the public arenaare through public debate and discourse, and through action in the courts for libel.

In much other social science and some humanities research, it is primarily the harmthat can result from violations of confidentiality that REBs and researchers needto address. This can pose a particular challenge in qualitative research because ofthe depth, detail, sensitivity and uniqueness of information obtained. The defaultapproach is to maintain confidentiality of the research data. In some instances,


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participants may waive anonymity (e.g., if they wish to be identified for theircontributions to the research). The researcher may accept the waiver of anonymityby the participant as long as such a waiver does not compromise the welfare ofother participants (see Article 3.2(f) and the Application of Article 5.1). In somecases, the researcher may decide to maintain the anonymity of the participant inpublications or dissemination of research results to ensure confidentiality of thedata and anonymity of other participants.

REBs need to be sensitive to whether anonymity, confidentiality or identificationis relevant in any given research context, and acknowledge that individuals maywant to be credited for their contribution by being named.

Researchers and REBs should consult Chapter 3 and 5 for additional details andconsiderations (see also Chapter 9).

Qualitative Research Involving Emergent Design

In qualitative research, emergent design involves data collection and analysis that can evolve overthe course of a research project in response to what is learned in earlier parts of the study. Specificquestions or other elements of data collection may be difficult to anticipate, identify and articulatefully in the research proposal in advance of the project’s implementation.

Article 10.5 In studies using emergent design in data collection, researchers shall provide theREB with all the available information to assist in the review and approval of thegeneral procedure for data collection.

Researchers shall consult with the REB when, during the conduct of the research,changes to the data collection procedures may present ethical implications andassociated risks to the participants.

Application Although initial research questions may be outlined in the formalized researchproposal, REBs should be aware that it is quite common for specific questions (aswell as shifts in data sources or discovery of data sources) to emerge only duringthe research project. Due to the inductive nature of qualitative research and theemergent design approach of the research, some of these elements may evolve asthe project progresses.

Researchers using emergent design shall provide the REB with all the availableinformation to allow for a proportionate approach to research ethics review of theresearch project. In cases where final versions of a questionnaire or interviewschedule have not been developed at the time of the ethics review of the researchproject, researchers should submit a draft set of sample questions, thematiccategories or other outlines of the procedures to be followed in data collection.Final versions should be submitted as soon as they become available. REBs shouldnot require researchers to provide them with a full questionnaire schedule in


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advance of data collection. Rather, REBs should ensure that the data collectionis conducted according to methodological requirements, and acknowledge thatquestionnaires or interview guides may change to adapt to emerging data orcircumstances in the field.

In emergent design, some resulting changes to the research design will notmerit requiring additional REB review, as they are not necessarily significantchanges to the approved research. Consistent with Article 6.15, where changesof data collection procedures would represent a change in the level of the riskthat may affect the welfare of the participants, researchers shall seek approvalfrom the REB prior to implementing such changes. Additional REB reviewand approval may be required (see Chapter 2 and Articles 6.14 and 6.15).

References

• Canadian Institutes for Health Research. CIHR Best Practices for Protecting Privacy in HealthResearch. September 2005.

• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council ofCanada, Social Sciences and Humanities Research Council of Canada, Access to ResearchResults: Guiding Principles.

• Canadian Institutes for Health Research, Natural Sciences and Engineering Research Council ofCanada, and Social Sciences and Humanities Research Council of Canada. Tri-Council PolicyStatement: Integrity in Research and Scholarship.

• National Health and Medical Research Council (Australia), Australian Research Council andAustralian Vice-Chancellors’ Committee. National Statement on Ethical Conduct in HumanResearch. 2007.

• Social Sciences and Humanities Research Council of Canada. SSHRC Research Data ArchivingPolicy.


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Chapter 11CLINICAL TRIALS

Introduction

This chapter focuses on the ethical issues involved in the design, review and conduct of clinicaltrials (as defined below). In particular, it addresses clinical trial design, therapeutic misconception,research-attributable risk, and other issues that may be unique to clinical trials. As clinical trialsare, perhaps, the most regulated type of research – subject to provincial, national and internationalregulatory bodies – reference will be made to these regulations, where appropriate. However, theemphasis in this chapter is on ethical guidance, grounded in the core principles of this Policy:Respect for Persons, Concern for Welfare, and Justice. As is the case throughout this Policy, thewelfare of participants takes precedence over the interests of researchers and sponsors.

For the purposes of this Policy, a clinical trial (a form of clinical research) is any investigationinvolving participants that evaluates the effects of one or more health-related interventions onhealth outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cellsand other biological products, surgical procedures, radiologic procedures, devices, genetictherapies, natural health products, process-of-care changes, preventive care, manual therapies andpsychotherapies. Clinical trials may also include questions that are not directly related totherapeutic goals – for example, drug metabolism – in addition to those that directly evaluate thetreatment of participants.

Clinical trials are most frequently undertaken in biomedical research, although research thatevaluates interventions, usually by comparing two or more approaches, is also conducted in relateddisciplines, such as psychology. The researcher leading a clinical trial is often (but not always) aclinician, that is, a health care provider (e.g., physician, dentist, naturopath, nurse, physiotherapist).Although various types and forms of clinical trials have methodological differences, the ethicalprinciples and procedures articulated in this Policy are applicable, and can be adapted as needed.Researchers and research ethics boards (REBs) should consult the other chapters of the Policyfor additional guidance on principles, norms and practices applicable to all research.

This chapter will require periodic revision, particularly in light of the ongoing efforts to developprovincial, national and international guidance for new methods and emerging areas of clinical re-search, including, but not limited to, clinical trials. Though much clinical research is observationaland evaluative such that previous chapters provide relevant guidance, there are plans to developadditions to the Policy that include both interventional clinical research (i.e., clinical trials) andencompass the fuller spectrum of non-interventional clinical research (e.g., public health research,epidemiology). This is in keeping with a commitment to the continued evolution of this Policy.

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A. Key Concepts

Risk and Proportionate Approach

Clinical trials, like other research covered by this Policy, are subject to a proportionate approachto research ethics review: trials that pose greater foreseeable risk to participants will receiveproportionately greater scrutiny (see Chapters 1 and 2). Not all clinical trials are high risk and careshould be taken to avoid an automatic classification of this nature. However, because clinical trialsoften involve large numbers of people, and may include people who are in vulnerablecircumstances due to health issues, the risk of serious harm or death must be considered. Themajority of clinical trials are classified as above minimal risk, and are reviewed accordingly. Thisis consistent with the principle of Concern for Welfare.

As discussed in Chapter 2, Section B, the evaluation of possible harms that participants mayexperience due to their involvement in research is of primary importance. The magnitude andprobability of these harms are described as foreseeable risks. In keeping with the principle ofRespect for Persons, it is the responsibility of researchers to clearly describe all foreseeable risksand potential benefits of their research to prospective participants in the consent process (seeArticles 11.4 and 11.5). It is the responsibility of the REB to weigh the foreseeable risks toparticipants against the potential benefits of the trial in the context of a proportionate approach toresearch ethics review, and to discuss with the researcher additional ways to eliminate or minimizerisks.

Clinical Equipoise

In trials where participants are randomly assigned to different groups (e.g., treatment A; treatmentB; no treatment), ethical issues relevant to the principle of Justice arise when one group may farebetter or worse than another (see Article 11.2 on placebo-controlled clinical trials). For this reason,clinical equipoise may be considered as a starting point for the design and review of clinical trials.Clinical equipoise means a genuine uncertainty exists on the part of the relevant expert communityabout what therapy or therapies are most effective for a given condition. This uncertaintynecessitates the conduct of research to determine the comparative therapeutic merits of existinginterventions (not all of which may be represented in a given clinical trial). Clinical equipoiseprovides a link between the duty of care of a clinician with the need to do research to ensure thatthe therapies or interventions offered are demonstrably safe and effective.

Duty of Care, Therapeutic Misconception and Dual Roles

Because clinical trials often involve clinicians and patients who have become participants, therelated issues of duty of care, therapeutic misconception and dual roles must be carefullyconsidered at the design and conduct stages by researchers, and at the review stage by REBs.

Duty of Care

The duty of care in a medical context is the obligation of clinicians to act in the best interests ofpatients. In the context of clinical trials, researchers are concerned with the welfare of individual

Chapter 11 – Clinical Trials

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participants, but are also focused on the generation of new knowledge that may or may not conferdirect benefits on participants. Nevertheless, researchers do have a duty of care to ensure that theforeseeable risks to participants are justified by the potential benefits, and that the safety ofparticipants is an integral part of the research design and conduct (see Articles 11.7 and 11.9).Duty of care also includes the researchers’ responsibility to communicate any information relevantto individual participants’ health to their primary clinician. Clinician-researchers (clinicians whoalso conduct research) need to manage any conflict that may arise from their dual role (see below)and they must also be particularly sensitive to the issue of therapeutic misconception.

Therapeutic Misconception

Although clinical trials may provide benefits to some participants, the purpose of a clinical trialis to evaluate an experimental therapy or intervention, not to provide therapy. Therapeuticmisconception occurs when trial participants do not understand that research is aimed primarilyat producing knowledge and may not provide any therapeutic benefit to them. It also occurs whenparticipants enter trials without understanding the ways in which elements of a clinical trial designmay interfere with their own health care objectives.

With the exception of some phase I trials, clinical trials usually involve individuals in need oftreatment, for whom the experimental therapy is hoped to be effective. Even when foreseeablerisks, potential benefits and treatment alternatives are explained to them, it is common that clinicaltrial patient-participants do not fully appreciate the differences between clinical care and researchparticipation. As a result, some patient-participants may assume that there must be therapeuticvalue in the research procedures they are undergoing, or that they have been invited to participatebecause their clinician believes it would contribute to their health.

Dual Roles of Clinician-Researchers

Research has shown that clinician-researchers may conflate their clinical practice with their clin-ical trial research. Some may be overly optimistic about the prospects of an experimentalintervention and overstate potential benefits or understate foreseeable risks to prospective partic-ipants. This can foster therapeutic misconception among patients and influence the recruitmentand consent process (see Chapter 3 and Article 11.6). Clinicians must take care not to create un-realistic expectations among participants with respect to the potential benefits of the research.

To preserve the trust on which their professional relationships with patients and colleagues reside,researchers should take all necessary measures to separate their role as researcher from their roleas clinician (e.g., enlist associates to recruit participants, rely on colleagues to determine when apatient should be withdrawn). It is important REBs appreciate the potential conflicts betweenthese roles and the possible impact on the welfare of prospective participants.

Principal Investigator

In studies involving more than one researcher, particularly multi-site studies, the researcher whohas overall responsibility for the ethical conduct of the study, and for the actions of any memberof the research team, is known as the principal investigator (PI). The PI is responsible for


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communicating any changes to the study, material incidental findings, new information, and/orunanticipated events to their own REB as well as to local site researchers, who must then informtheir local REBs.

B. Clinical Trial Design and Registration

This section discusses ethical issues associated with the design and registration of clinical trials.Guidance for the most common types of clinical trials (pharmaceuticals, medical devices) as wellas other types of trials (natural health products, psychotherapy and surgery), is provided in sub-sections of the Application of Article 11.1. Though not all possible clinical trial designs arerepresented in this section, the guidance provided can be applied and adapted as needed.Researchers are advised to consult the relevant provincial, national and international regulatorydocuments to design their clinical trial (see References at the end of the chapter). In all clinicaltrials, researchers and REBs should be aware of ethical issues including, but not limited to,registration, safety, selection and recruitment of participants, undue inducement, consent,dissemination of findings, and real, potential or perceived conflicts of interest.

Article 11.1 In the design and review of a clinical trial, researchers and REBs shall considerthe type of trial (e.g., pharmaceutical, natural health product, medical device,psychotherapy), its phase (if appropriate) and the corresponding particular ethicalissues associated with it, in light of the core principles of this Policy.

Application Each type of clinical trial has specific ethical issues that correspond to the risksfaced by the participants. In a proposal submitted for research ethics review, theresearcher shall clearly specify the type of trial proposed (and, where relevant, itsphase), identify the foreseeable risks and potential benefits to participants, andshow how this information will be clearly communicated to participants in theconsent process (see Article 3.2).

REBs reviewing clinical trials need to be familiar with the ethical issues raised bydifferent phases, and by different types, of clinical trials. If an REB does not havemembers with the appropriate expertise to review a particular trial, then it shallseek out someone with the necessary expertise to consult as an ad hoc advisor (seeArticle 6.5).

This guidance applies equally to continuing research ethics review, includingrequests to make changes to the method, statistical procedures, inclusion/exclusioncriteria, or other elements of approved research, as required by this Policy (seeArticle 6.14 and 6.16).

Pharmaceutical Trials

Clinical trials involving pharmaceutical products are commonly categorized intofour phases, each of which gives rise to particular ethical issues. Detailed


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descriptions of the phases of clinical trials are provided in other guidancedocuments (see References). The ethical concerns described are most likely to arisein a specific phase of a clinical trial. Some issues may arise at any phase of aclinical trial.

Phase I

Safety concerns are particularly acute in phase I research because it may be thefirst time participants are exposed to the new drug (“first-in-human” trials), andthere may be little or no experience with the drug. Phase I trials often depend onhealthy participants who are offered incentives for their participation, though thisis not usually the case in, for example, cancer trials. Increasingly, phase I trialsinclude participants with specific diseases for whom conventional therapy hasfailed. The combination of clinical risk with uncertain or no likelihood of clinicalbenefit, and the often substantial incentives offered to participants, raises ethicalconcerns about safety, the selection and recruitment of participants, and the consentprocess. For safety, it is important to ensure that the drug is initially given to asmall number of participants and that dosing is increased in clearly definedincrements only after participants’ responses to the initial dose is known.Recruitment and consent procedures shall ensure that participants are aware of theuntested nature of the therapy and that participants do not accept, because of theincentives being offered, risks they would otherwise refuse.

Phase II

Phase II or combined phase I/II clinical trials raise particular ethical concerns,because they are often conducted with populations whose therapeutic options havebeen exhausted. Examples include patients with cancer that is incurable by standardtherapies and HIV/AIDS, or people with conditions that cause them acute orchronic pain. These circumstances may affect the perceptions of patients and theirfamilies as to the balance between the risks and potential benefits of the trial andthus may affect their decision whether to participate. Additionally, becauseparticipants in phase II trials may include patients who are unwell and frequentlynot working, the REB should ensure incentives for participation are not coercive,and patients do not accept risks they would otherwise refuse because of theincentives being offered. Researchers should be encouraged to consult with theREB at an early stage about any recruiting, consent or safety issues that arise.

During the course of a phase II clinical trial, patients will have access to a newdrug that may be efficacious (provide clinical benefit). Researchers shall: a) as partof the consent process, provide details on access to the new drug upon trialcompletion; and b) make reasonable efforts to secure continued access to the drugfollowing the phase II trial, for those patients for whom the drugs appear to beefficacious.


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Phase III

The REB should carefully examine phase III clinical trials to ensure that the careof patient-participants is not compromised in the random assignment to any armof the trial (including the placebo arm – see Article 11.2). Researchers should alsoprovide a plan for interim analysis of data, early unblinding of clinicians and/orpatients, and/or ending the trial if the drug should prove effective or harmful. TheREB should evaluate such plans with due consideration for the welfare of theparticipants and the group which is the focus of the research (see Article 3.2 [l]).

Researchers and the REB should also address the issue of continuing access to theexperimental therapy after the trial closes. If the treatment benefits participantsand is safe, the proposal should state whether it will continue to be provided andunder what conditions. REBs should be concerned about what provisions arepossible to ensure that participants continue to receive adequate treatment.

Phase IV

Phase IV trials can be valuable for assessing the long-term safety and effectivenessof marketed drugs and devices. Earlier-stage trials are of limited duration, andsubsequent research can identify side effects, toxicities, drug interactions andoverall tolerance that may only emerge over time. However, in some cases, phaseIV trials may be designed to serve primarily as marketing initiatives to encouragethe prescription and continued use of an approved drug. For example, a clinicianmay be paid a per capita fee by a sponsor to collect data on the side effects andacceptance by patients of a drug being marketed by that drug’s sponsor. REBsshould carefully consider the financial terms between sponsors and investigatorsassociated with these trials as they may create problems such as inappropriateprescription practices, billing practices and/or inappropriate utilization of publicresources (e.g., diagnostic services and medical imaging). Researchers and REBsmust ensure that trials are undertaken for a bona fide scientific purpose, whichincludes a design and objective(s) that are scientifically, rather than commercially,driven. Phase IV trials designed with the primary goal of increasing sales do notconstitute legitimate research.

Natural Health Product Trials

Natural Health Products (NHPs) may be viewed as safe simply because they arenatural. Some NHPs, however, can pose serious health risks. NHPs may also bepart of a multi-treatment therapeutic approach (e.g., a herbal medicine added to aconventional medicine or to a complementary alternative therapy). A researchproposal for an NHP clinical trial shall clearly identify the known effects of theproduct under investigation and its possible contraindications. REBs should ensurethat NHP clinical trial proposals are reviewed with the appropriate level of scrutinyas indicated by the foreseeable risks to the participants.


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In evaluating the research design REBs should consider the history of the NHP asprovided in the literature review contained in the researcher’s brochure and/or ina monograph (such as those published by Health Canada setting out approved usesand cautionary information). For NHPs with an established safe history of humanuse, the researcher does not have to present the findings of prior testing withanimals, if the proposed conditions of use in the trial do not differ from approveduses. However, if the NHP is a new product without an established safe history ofhuman use, prior animal testing may be necessary before it can be approved forfirst-in-human trials.

Since 2004, the conduct of clinical trials involving NHPs has been subject toregulations under the Food and Drugs Act and the Natural Health ProductsDirectorate (NHPD) of Health Canada. Researchers and REB members areresponsible for knowing how these regulations affect the design and conduct ofNHP clinical trials.

Medical Device Trials

Medical devices may take many forms (e.g., a magnetic resonance imagingmachine, a cardiac pacemaker, a hip implant). The term “medical device” covers awide range of instruments used in the prevention, diagnosis, mitigation, ortreatment of a disease or abnormal physical condition or the restoration, correctionor modification of body function or structure. The conduct of clinical trialsinvolving medical devices is subject to regulations under the Medical DevicesBureau of Health Canada. Researchers and REB members are responsible forknowing how these regulations affect the design and conduct of medical deviceclinical trials.

Researchers are responsible for providing up–to-date information about the device,for example, any feasibility studies it has been subject to in Canada or in othercountries, and its risk classification. If an REB does not have enough safetyinformation about the device to consider in its review of the trial, the researchershould be advised to work with the manufacturer of the device to provideappropriate risk information in the research proposal.

In any case, REBs should satisfy themselves (with the assistance of externalexpertise, if necessary) that the use of the device in the trial is appropriate and thatthe foreseeable risks to participants are justified by the potential benefits.

Psychotherapy Trials

A clinical trial testing a psychotherapeutic approach to behavioural disorders orother mental illness may compare the outcomes of two or more patient populationswith the same diagnosis but receiving different therapies; or a trial may comparethe outcome of those who have received a therapy with those who are on thewaiting list for treatment. Often a trial will compare a behavioural therapy approachwith a pharmaceutical treatment approach or some combination of both. REBs


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should have a member knowledgeable in the relevant area to assess the ethicalissues specific to the type of therapy involved.

REBs should be aware that trials involving psychotherapy may be more focusedon effectiveness in real world conditions than on efficacy under tightly controlledconditions. For example, the research question may be how participants undergoinga particular therapy are functioning in their daily lives. The duration of these trialsmay be longer as a function of the therapeutic approach and the characteristics ofthe condition to which it is applied. Particular areas of concern are whether theprincipal investigator or others on the research team are sufficiently trained toprovide the investigational therapy and whether there is any risk of a negativeimpact on participants’ mental health.

Issues of participant privacy and confidentiality may receive closer scrutiny incases where people with specific psychological profiles are being recruited fromthe same institution as the researchers. Researchers shall indicate how recruitment,data collection and management, and compensation procedures have been designedto protect participant confidentiality (see Chapter 5).

Surgical Trials

Some of the issues surrounding the comparison of different surgical techniquesare the appropriateness of the technique to the participants, whether the techniquehas been validated, whether the tools required have been approved for use inCanada, how well the experimental procedures have been explained to prospectiveparticipants, and whether it is appropriate to employ a control group that undergoessham surgeries. When there is a crossover from medical to surgical treatment itcan be difficult to assess whether participants’ health outcomes were due to thesurgical intervention. The risk of subjecting participants to a potentiallyscientifically inconclusive trial needs to be weighed against the risk of subjectingthem to a potentially harmful placebo intervention.

REBs should be aware that it is possible that the principal investigators of surgicalclinical trials need not, themselves, be a surgeon or technician trained in theprocedure. For example, a biomechanical engineer who has developed a new typeof skin graft material to aid in surgical repair, may conduct a surgical clinical trial,with the assistance of a surgical team, to compare the new material with an existingmaterial.

Placebo-Controlled Trials

A clinical trial in which one or more intervention arms are compared with a placebo control groupraises specific ethical issues. Where there is an established effective treatment, use of a placebomay deprive participants of needed therapy. It is the responsibility of the researcher or sponsor toprovide justification to the REB for the choice of a placebo control group, as opposed to the otherpossible choices of control group (e.g., active control, wait-list control, dose-response and


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combination therapies). The following article sets out criteria for the use of a placebo controlgroup to ensure that this type of clinical trial design is used only in situations that do notcompromise the safety and welfare of participants.

Article 11.2 (a) A new therapy or intervention should generally be tested against an establishedeffective therapy.

(b) As with all alternative choices of a control, a placebo control is ethicallyacceptable in a randomized controlled clinical trial only if:

• its use is scientifically and methodologically sound in establishing theefficacy or safety of the test therapy or intervention; and

• it does not compromise the safety or health of participants; and

• the researcher articulates to the REB a compelling scientific justificationfor the use of the placebo control.

(c) For clinical trials involving a placebo control, the researcher and the REB shallensure the general principles of consent are respected and that participants ortheir authorized third parties are specifically informed (see Article 3.2):

• about any therapy that will be withdrawn or withheld for purposes of theresearch; and

• of the anticipated consequences of withdrawing or withholding the therapy.

Application All clinical trials involve risk to participants. For all approved trials: a) the welfareof the participants needs to be upheld under the specific conditions of the trial; andb) the trial needs to be scientifically sound. Risks to the safety of participants cancome from lack of efficacy or from undesirable side effects. These risks must beassessed for each treatment arm, including the experimental and control arm(s).The choice of control arm, which may range from currently approved treatmentsto placebo, placebo add-on, or no treatment, should, like all research, meet anacceptable risk-benefit ratio. As with other aspects of the trial design, the choiceof control arm must be justified based on scientific, medical and methodologicalreasons.

According to Article 11.2, researchers should consider a proven effective therapyas a control if one is available. The implications of various choices of trial designdirectly affect the interpretability of trial results, and a trial that cannot return usefulinformation is by definition not ethical. Good science is a necessary, albeitinsufficient, condition for good ethics. To properly assess the ethics of a placebo-controlled superiority design vs. an active controlled non-inferiority design, anappreciation of the interplay of ethics and science is required (see Article 2.7).Conditions that work against carrying out a non-inferiority trial successfullyinclude low and/or variable response to treatment, and high placebo response. The


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researcher must provide adequate justification for the use of a non-inferioritydesign.

Participants in the test arm of a trial of a new therapy are not receiving proveneffective therapy. Risks to the safety of participants can come from lack of efficacyor from undesirable side effects. These risks should be assessed for each treatmentarm, including the experimental and control arm(s).

The use of an active treatment comparator in a clinical trial of a new therapy isgenerally the appropriate trial design when an established effective therapy existsfor the population and clinical indication under study.

Great care should be taken to avoid abuse of placebo comparators. However, theyare acceptable in any of the following situations:1) there are no established effective therapies for the population or for the

indication under study;

2) existing evidence raises substantial doubt within the relevant expert communityregarding the net therapeutic benefit of available therapies;

3) patients are resistant to the available therapies by virtue of their past treatmenthistory or known medical history;

4) the trial involves adding a new investigational therapy to established effectivetherapies: established effective therapy plus new therapy vs. establishedeffective therapy plus placebo;

5) patients have provided an informed refusal of established effective therapy,and withholding such therapy will not cause serious or irreversible harm.

The determination of response satisfaction and refusal of treatment must take placeoutside the context of recruitment for the clinical trial and prior to offering trialparticipation to the prospective participant, and both must be documented.1

The use of a placebo comparator in situation (5) is permitted because prospectivetrial participants are not using established therapies and therefore are not benefitingfrom therapy. For that reason, such participants would not be further disadvantagedif enrolled in a placebo-controlled trial than participants in a trial for whom thereare no established effective therapies for the indication under study. Researchproposals submitted to REBs shall include sufficient support and justification ofthe trial design and use of placebo comparator.

Clinical Trial Registration

There are compelling ethical reasons for the registration of all clinical trials. Registration improvesresearchers’ awareness of similar trials so that they may avoid unnecessary duplication and therebyreduce the burden on participants. Registration also improves researchers’ ability to identifypotential collaborators and/or gaps in research so that they may pursue new avenues of inquiry


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with potential benefits to participants and to society. Perhaps of most concern is the danger thatsome researchers or sponsors may only report trials with favourable outcomes. Failing to reportthe outcome of a trial or withholding negative findings is more difficult when all trials must beregistered.

The registration of clinical trials upholds the principles of Respect for Persons, Concern forWelfare, and Justice, by ensuring that the efforts of all participants in clinical trials areacknowledged, and by reducing the potential for endangerment of others through publication bias.

Article 11.3 All clinical trials shall be registered before recruitment of the first trial participantin a publicly accessible registry that is acceptable to the World Health Organization(WHO) or the International Committee of Medical Journal Editors (ICMJE).

Application Clinical trial registries are intended to increase transparency and accountability byproviding a record of clinical trials at the recruitment stage that can be used tolocate publications of trial results (see Article 11.12). This helps prevent publicationbias, that is, the selective publication of only those trials that yield results in supportof an intervention. These registries, in addition to agency policies, editorial policies,ethical policy reforms, and revised national and institutional ethics policies andresults disclosure requirements, contribute to a multi-faceted approach to eliminatenon-disclosure. The collective goal is to reduce publication bias, and prevent thesuppression of data in clinical research.

Clinical trials shall be registered in a publicly accessible registry that is acceptableto the World Health Organization (WHO) or the International Committee ofMedical Journal Editors (ICMJE). All fields outlined in the WHO Trial RegistrationData Set (TRDS) must be completed in order for a trial to be considered fullyregistered. A registration with missing information or uninformative fields in theTRDS is unacceptable. Researchers shall provide the REB with the numberassigned to the trial upon registration.

C. Assessing Safety and Minimizing Risk

Participants enrolled in clinical trials are commonly exposed to investigational therapies,interventions, drugs or devices, each of which carries specific, and possibly unknown, risks.Because of the nature of clinical interventions, the potential harms can be physical, psychologicalor social, and may cause lasting, irreparable damage. In accordance with the core principles, it isthe responsibility of researchers and REBs to ensure that (a) foreseeable risks to participants areminimized, and appropriately evaluated alongside potential benefits, (b) participants are clearlyinformed as to the nature of these foreseeable risks and potential benefits, (c) participant safety ismonitored and accurately reported, and (d) any new information that may impact on the welfareof participants, or their decision to remain involved in a trial, be shared appropriately.

Article 11.4 Researchers and REBs should ensure that the foreseeable risk to participants inclinical trials is: (a) justified by the potential benefits to be gained; and (b)appropriately minimized.


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Application The researcher has a responsibility to present the proposed research in the contextof a systematic review of the literature on that topic. Clinical trials should not beconducted unnecessarily on questions that have already been definitively answered.

The proportionate approach to research ethics review (see Chapter 2, Section B)dictates that trials deemed to be of greater risk should be subject to proportionatelygreater scrutiny. In all clinical research, the REB should carefully evaluate previouslaboratory, animal and human research with a drug or other therapy, and/or havean expert evaluation undertaken on its behalf, to ensure that the foreseeable riskfrom its use is: (a) justified by the potential benefits to be gained; and (b)appropriately minimized.

Where appropriate, based on reports of safety issues arising in the trial, an REBmay discontinue the trial at its institution, require the disclosure of relevant safetyinformation to existing and future participants (see Articles 6.3 and 6.15), or takeother steps that are reasonably necessary to promote the safety of participants, suchas unblinding.

Article 11.5 When describing the foreseeable risks and potential benefits of research involvingparticipants who are undergoing high-risk therapies, researchers should clearlyindicate which risks are attributable to the research (including cumulative risks),and which risks the participants would normally be exposed to in the course oftheir clinical care.

In their evaluation of risk, REBs should ensure that they are evaluating only thoserisks that are attributable to the research (including cumulative risks), and notcompounding them with the risks attributable to clinical care.

Application The evaluation of foreseeable risk to participants in a clinical trial can becomplicated if the prospective participants are already exposed to risks in thecourse of their clinical care. It is the researcher’s responsibility to clearlydistinguish in their research proposal between the risks due to clinical care and theforeseeable risks of the clinical trial.

The REB must take into consideration the ethical implications of recruitingpatients, particularly those receiving high-risk therapies, into clinical trials thatmay offer additional risk. In accordance with Articles 4.1 and 4.7 on vulnerabilityand inclusion/exclusion criteria, patients who are receiving high-risk clinical careshould not be inappropriately included in, or excluded from, participating inresearch.The REB may approve clinical trials involving participants who are exposed torisk in their usual clinical care, where the REB finds a favourable balance betweenthe foreseeable risks attributable to the research and the potential benefits.

In addition to describing any other available treatments (including no treatment),researchers must ensure that prospective participants are informed of the


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foreseeable risks and potential benefits attributable to the research, as distinct fromthose arising from their clinical care. REBs should ensure that all consent materialsreflect this distinction.

Article 11.6 REBs and clinical trial researchers should be conscious of the phenomenon oftherapeutic misconception, and ensure that procedures for recruitment and consentemphasize which specific elements of a clinical trial are required for researchpurposes, as well as the differences between research and the standard clinical carepatients might otherwise receive.

Application When treating clinicians conduct research with their patients, special efforts maybe required, as part of the consent process, to distinguish between their dual role– clinician and researcher – and to ensure that patients who become participantsunderstand the differences between the goals of health care and the goals ofresearch.

It is important that clinician-researchers take care not to overplay the benefits ofresearch participation to patients in vulnerable circumstances, who may be misledto enter trials with false hopes. Research has shown that clinicians can affect howwell their patients appreciate the uncertainty of research, the seriousness andmagnitude of risks, and the possibility that participation may not result in any directbenefits to their own health status. Article 3.2 describes the requirements for consent to research participation. Itindicates that participants shall be provided with relevant information, including aclear description of those elements of participation that are experimental in natureand those not primarily intended to benefit the participant directly.In general, therapeutic misconception can be minimized by ensuring that theclinicians who provide the patient’s regular care are involved as little as possiblein the recruitment and the consent process. Ideally, treatment and research functionsshould be performed by different people. However, there may be instances in whichparticipants’ best interests are served by having their primary care clinicianinvolved in recruitment and consent. In these cases, the research proposal shallindicate what other measures will be taken to minimize therapeutic misconception.

Monitoring Safety and Reporting New Information

In accordance with the core principle of Concern for Welfare, it is a key responsibility ofresearchers and REBs to ensure that, as clinical trials proceed, the risks to participants remain inthe acceptable range, and the safety of participants is monitored. Articles 11.7 and 11.8 addressresearchers’ responsibility to include a safety monitoring plan in their proposal submitted for REBreview, and their responsibility to ensure that any new information that may affect participantwelfare or consent is shared with the REB and participants (see also Articles 6.15 and 6.16).Article 11.9 addresses the REB’s responsibility to have procedures in place to receive and respondto reports of new information, including, but not limited to, safety data, unanticipated issues andnewly discovered risks (see the Application of Article 11.8 for an expanded definition).


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In the case of clinical trials, there are provincial, national and international guidelines that governsafety monitoring and reporting of new information. It is the responsibility of researchers to beaware of the guidelines that apply to their research (see References) and to adhere to them for thesafety and benefit of participants.

Roles and Responsibilities in the Sharing of New Information

Typically, researchers in charge of a trial at a particular site are responsible for communicatingnew information to their REB, to participants and, in the case of multi-site research, to the principalinvestigator. In single-site clinical trials, such researchers will likely be the principal investigator(the leader of the trial who is responsible for its ethical conduct). In this chapter, the term“researcher” is used in the context of communication with REBs and participants, and the term“principal investigator” is used in the context of communication among researchers involved ina multi-site trial.

Trials may also have sponsors who can be a source of new information. Sponsors may be theprincipal investigator (investigator-initiated trials), a research institution or another type oforganization (e.g., private company, not-for-profit association). When principal investigatorsreceive new information, from the sponsor or any other source related to the trial, they areresponsible for communicating this new information to their own REB, as well as to local siteresearchers, who must then inform their local REBs.

The extent to which new information is shared with participants depends upon the nature of theinformation, and the REB’s evaluation of whether it affects the welfare or consent of some or allparticipants. In the case of multi-site trials (also known as multi-jurisdictional trials), the rolesand responsibilities of the principal investigator, researchers and sponsor may vary depending onthe model of research ethics review in use (see Chapter 8).

Article 11.7 Researchers shall provide the REB with an acceptable plan for monitoring thesafety of participants, including a plan for the tabulation, analysis and reporting ofsafety data, and the sharing of other new information in a form that permits REBsto interpret and respond appropriately.

Application Researchers and REBs must ensure that every clinical trial proposal includes aplan to assess safety concerns and protect the ongoing safety of participants. Theresponsibility of establishing a safety monitoring plan is the responsibility of theresearcher. This plan shall include the requirement that researchers provide REBswith clear and up-to-date information about the safety of participants taking partin clinical research. These summary reports should be provided promptly andinclude information about the context and significance of reported data to permita fair interpretation and meaningful review by the REB for the protection ofparticipants. When the REB requires additional information, the researcher shallprovide it. If necessary, the REB may require that this evaluation shall be conductedby a qualified source, independent of any sponsor, who has no conflict of interest(see Chapter 7).


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Any safety monitoring plan should include a mechanism by which researchers mayremove participants for safety reasons and by which clinical trials may be stoppedor amended if they are found to be unsafe, or for reasons of futility (e.g., it isdetermined that the trial is unlikely to produce valid results) or efficacy (e.g., oneor more interventions are found to be successful).

A safety monitoring plan may (but need not) include the establishment of a datasafety monitoring board (DSMB) or data safety committee (DSC).

A DSMB is normally a multidisciplinary, expert advisory group that is responsiblefor safeguarding the interests of participants, by reviewing emerging data, assessingthe safety and efficacy of trial procedures, and monitoring the overall conduct of atrial. Researchers must indicate, in their proposal for REB review, whether they ora DSMB will be communicating any new information to the REB over the courseof the trial. Researchers must ensure that DSMB reports are sent to REBs in atimely manner.

The appointment of a DSMB does not alter the responsibilities of researchers andREBs to monitor participant safety. In the context of multi-site trials, when newinformation at one site may be relevant to participant welfare and consent at othersites, principal investigators must ensure that this information is shared withresearchers at each site, and researchers must ensure that the REB also receivesthese reports (Article 11.8). The REB must be prepared to act upon these reports,especially where urgent action is required (see Article 11.9).

Article 11.8 Researchers shall promptly report new information that may affect the welfare orconsent of participants, to the REB, and to other appropriate regulatory or advisorybodies. New information must be submitted to the publicly accessible trial registryalong with reports of findings once the trial is completed. Where possible, thisinformation can be reported earlier to the registry in descriptions of study design,intervention, or an equivalent data field. When new information is relevant toparticipants’ welfare, researchers shall promptly inform all participants to whomthe information applies (including former participants). Researchers shall workwith their REB to determine which participants must be informed, and how theinformation should be conveyed.

Application In the course of any type of clinical trial, new information may arise that is relevantto participants’ welfare and/or their ongoing consent to participate (see Article 2.8,Article 3.3, Articles 6.15 and 6.16, and Article 11.8). This new information mayarise from unanticipated issues (e.g., adverse reactions to interventions) or fromroutine evaluations of participant health that occur in the context of the trial. It maypertain to all participants, or only to those in one arm of a trial, or only to oneparticipant with a particular health issue. It may be information that arises fromother related research that has repercussions for ongoing trials. To understand theparticular relevance of new information, it should be considered from theperspective of the participant. Article 11.8 outlines the continuing duty of


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researchers to share new and relevant information regarding clinical trials with theREB, the publicly accessible registry where the trial is registered, other relevantbodies, and with participants and their primary care clinicians, as indicated by thenature of the information. The more relevant, serious and urgent the information,the more promptly it should be disclosed.

New information that arises outside the trial (e.g., new findings in other relatedresearch) must also be disclosed when that information is relevant to theparticipant’s ongoing consent to participation. Researchers should also promptlyshare new information about an intervention with other researchers or cliniciansadministering it to participants or patients, and with the scientific community – tothe extent that it may be relevant to the general public’s welfare. New informationthus covers a range of matters that includes, but is not limited to, the following:

• changes to the research design;

• evidence of any new risks;

• unanticipated issues that have possible health or safety consequences forparticipants;

• new information that decisively shows that the benefits of one interventionexceed those of another;

• new research findings, including relevant non-trial findings;

• unanticipated problems involving lack of efficacy, recruitment issues or othermatters determined to be serious enough to warrant disclosure; or

• closure of trials at other sites for reasons that may be relevant to the welfare orconsent of participants in the ongoing trial.

The duty to report new information to the REB, along with the necessary analysisand evaluation to make the new information interpretable, lies with the researcher.In the case of newly discovered risks or unanticipated issues, the report shall alsoinclude a plan to eliminate or mitigate any increased risks to participants. The REBshould encourage researchers to raise potentially relevant developments with theREB at an early stage to better determine the appropriate scope and timing ofinformation sharing with participants and regulatory authorities.

When new information is relevant to the welfare of all participants, thenresearchers and REBs have a duty to ensure that all participants are informed.Where new information affects only current participants in the trial, the REB maydecide that former participants need not be informed. However, researchers maydecide to voluntarily share this information with all participants if they choose.

In multi-site clinical trials, when new information arises at one site that may affectparticipant welfare or consent at other sites, the researcher in charge of that siteshall promptly inform the principal investigator of the trial. The principal


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investigator shall inform researchers at all other sites of the trial. It is theresponsibility of the researcher in charge of each site to ensure their REB receivesthis information in a timely fashion.

The welfare of participants must also be considered when a trial is unexpectedlydiscontinued. When a researcher, a sponsor or other body (institution, fundingagency, regulatory body) stops or unblinds a clinical trial, or a part of a clinicaltrial, the principal investigator has an ethical and a regulatory responsibility toinform both clinical trial participants and the REB of the discontinuance orunblinding and the reasons for it. Researchers must update the publicly accessibletrial registry with any changes to the trial that require REB review and approval,adverse events that occur during a trial, and decisions taken to end a trial early. Inthe case of a trial that has stopped early, an explanation must be provided as partof the update to the registry. Where no specific field for this information exists,this update can be added to descriptions of study design and/or intervention (or anequivalent data field). Any risks to participants that may arise from the closing ofthe trial must be communicated in writing to the REB and the participants, and theresearcher shall indicate any measures that will be taken to mitigate these risks.

New information affecting the welfare of former participants may arise after thecompletion of the trial or after the participants’ involvement is finished. If so, theresearcher should share the information with the REB and other appropriateregulatory or advisory bodies. The REB and the researcher should considerwhether, given its nature and urgency, the information would be relevant to anyformer participants’ welfare and informed choices, as well as to ongoing researchelsewhere, and the general public. If so, reasonable steps should be taken byresearchers to inform former participants, and to publicly disclose the information,in a meaningful and timely manner.

Article 11.9 REBs shall develop procedures to review safety reports and other new informationarising from clinical trials that may affect the welfare or consent of participants,and to take appropriate steps in response.

Application In accordance with Articles 11.7 and 11.8 and Articles 6.15 and 6.16, REBs canexpect to receive safety reports and new information, including, but not limited to,unanticipated issues, changes to the research design and newly discovered risks.The reports are usually submitted by the local site researcher, who may also be theprincipal investigator, or by an established safety monitoring body, such as a DSMB(see Article 11.7). REBs should be aware that researchers are also required to updatethe publicly accessible trial registry where their trial is registered (see Article 11.8).

It is the REB’s responsibility to establish procedures for reviewing safety reportsand new information, to determine how they will respond to increased risks toparticipants, and to be ready to implement these responses as needed. Responsesshall be relative to the seriousness and likelihood of the risk to the welfare of


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participants within their jurisdiction. REBs may advise researchers as to the stepsthey must take to eliminate or mitigate newly reported risks, and how thisinformation should be shared with participants (see Article 11.8). In exceptionalcases, REBs may decide to suspend new recruitment, or to suspend all participantinvolvement in a trial pending further investigation.

D. Financial Conflicts of Interest

Clinical trials can be affected by all types of conflict of interest: personal, professional and/orinstitutional (as described in Chapter 7). Article 11.10 deals specifically with financial conflictsof interest that are of concern for sponsored clinical trials.

Sponsored Research

Article 11.10 Researchers and REBs should be aware of, and consider the possibility of, financialconflicts of interest. They should ensure that clinical trials are designed to meetappropriate standards of participant safety in accordance with the core principlesof this Policy. Financial considerations shall not affect these standards or thescientific validity and transparency of trial procedures.

Application Researchers should not benefit financially from pharmaceutical or biotechnologycompanies, or other types of sponsors. Financial incentives have the potential todistort researchers’ judgment in ensuring the design and conduct of the trial isethical. Some clinical trials are conducted under contract with companies that havea profit motive in order to secure marketing approval for the drug, device orproduct being tested. Because these companies operate on a profit-based model,the financial benefits of demonstrating efficacy and safety in a novel therapy mayhave the effect of compromising standards of participant protection and scientificvalidity (see Chapter 7). Financial conflicts of interest are not a feature of allsponsored research. However, REBs shall consider the potential for conflicts ofinterest in clinical trials because it has been empirically established as a risk ofsome sponsored research and can undermine the ethical conduct of research.

Clinical Trial Budgets

Budgets for clinical trials are usually calculated based on per capita costs – that is, the sponsorpays the researcher a fixed sum for each participant, based on the duration and complexity of thetrial and the tests and procedures it requires.

Article 11.11 REBs shall ensure that clinical trial budgets are reviewed to ensure that conflictsof interest are identified and minimized, or otherwise managed.

Application REBs may delegate the review of clinical trial budgets to an appropriateinstitutional body. The body should ensure financial conflicts of interest arereported to the REB. When no such institutional body exists, the REBs shall reviewclinical trial budgets for financial conflicts of interest. As a general guide, payments


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for clinical trial procedures should be no greater than the usual amounts chargedby health care providers for the provision of comparable services. Researchersshould disclose all kinds and amounts of payment to the REB (see Article 7.4).

A particular concern in the context of clinical trials is the use of inappropriateincentives by the sponsor to encourage researchers to recruit participants quicklyand without regard to their suitability for the trial. Differential incentives paid fordifferent levels of recruitment, such as higher per-participant payments for thoserecruited above a set target, may also encourage inappropriate recruitment practicesand should be prohibited. The REB can assist the researcher in identifying theseand other types of financial conflicts and managing them appropriately (see Article7.4).

E. Analysis and Dissemination of Clinical Trial Outcomes

The rights of sponsors with respect to the analysis of data, interpretation of results and publicationof findings, and ownership thereof, are typically described in sponsor-researcher contracts (oftenreferred to as clinical trial agreements), which are reviewed by the institution. These contractsmay seek to place restrictions on the publication of findings, either directly or through provisionsthat seek to protect, in favour of the sponsor, the intellectual property of research procedures, dataor other information. It is the responsibility of the institution to ensure that these contracts are incompliance with the guidance of this Policy, and in particular Article 11.12.

Article 11.12 With respect to research findings:

(a) Institutions and REBs should take reasonable measures to ensure that sponsors,researchers and institutions publish or otherwise disseminate the analysis ofdata and interpretation of clinical trial results (i.e., the findings) in a timelymanner without undue restriction.

(b) Any prohibition or undue limitation on the publication or dissemination ofscientific findings from clinical trials is ethically unacceptable.

(c) Institutions should develop reasonable written policies regarding acceptableand unacceptable clauses in clinical trial research contracts relating toconfidentiality, publication and access to data.

Application To justify the involvement of participants, and the risks and other burdens they areasked to bear, research must be valuable. That is, it must have a reasonablelikelihood of promoting social good. If research findings and the research materialsand research data they are based upon, are not disseminated (e.g., published in apeer-reviewed journal, added to a publicly available clinical trials database) withina reasonable time, their value may be diminished or lost, betraying thecontributions and sacrifices of participants. For this reason, and based on respectfor participant expectations and protection of the public good, researchers, research


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sponsors and institutions have an ethical responsibility to make reasonable effortsto publicly disseminate the findings of clinical trials in a timely manner bypublications and by the inclusion of the findings (where possible), or informationabout where to access findings (e.g., lists of publications, links to publications orto the trial website) in the publicly accessible registry where the trial has beenregistered. In publications, researchers have the obligation to report trial details(for example, method, all planned outcomes, and harms as defined by theConsolidated Standards of Reporting Trials4). Furthermore, any new informationthat has an effect on the welfare of participants that comes to light at, or after, theend of the trial should be reported in subsequent publications.

However, negative findings of research are not always published or otherwisedisseminated. Clinical trial registries do not currently require dissemination offindings. Failing to publish negative findings could lead to publication bias andthus contribute to a series of risks, including misinformed clinical decision makingbased on incomplete or skewed data, inappropriate and potentially harmful clinicalpractices and injury to health, needless and wasteful duplication of research withassociated risks to participants,, fraud or deception in the clinical trials process,and erosion of public trust and accountability in research.

Although it is beyond the scope of the Policy to provide guidance for journaleditors and publishers, both have ethical obligations with regard to the publicationof the findings of research. Both negative and positive findings should bepublished. Sources of funding, any restrictions regarding public disclosure of trialdata, institutional affiliations and conflicts of interest should be declared inpublications.

Researchers are encouraged to make their data available for further analysis orverification by their peers. When sharing participant data with peers, researchersmust be mindful of their responsibility to safeguard participant privacy andconfidentiality (see Articles 3.2, 5.1 and 5.5A) and may have to code or anonymizethe data to do so.

Confidentiality clauses and publication restrictions in research contracts

Institutions and REBs should require the satisfactory amendment or removal ofany confidentiality clauses or publication restrictions in research contracts thatunduly limit either the content of the scientific information that may bedisseminated or the timing of dissemination. Contracts should also ensure thatprincipal investigators have the necessary access to original trial data, and theopportunity to analyze them, to ensure that they can report trial findings fairly andaccurately, particularly with respect to both efficacy and safety.

Institutional and REB policies should ensure that sponsors’ legitimate interests arereasonably balanced against the researcher’s ethical and legal obligations toparticipants, and to the scientific and public good to disseminate data and research


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findings (see Chapter 7 with respect to Conflicts of Interest). It shall be understoodthat the welfare of participants takes precedence over the interests of bothresearchers and sponsors.

Such policies should require that clinical trial research contracts be examined toensure that contractual provisions comply with institutional policy standards. Theyshould do all of the following:

1) require that confidentiality and publication clauses be submitted to a respon-sible authority (e.g., the REB or research administration) for a determinationof their consistency with the policy;

2) require that any ethical concerns arising in the review be referred to the REBas an integral part of the research ethics review process;

3) provide that any proposed restrictions on publication include an ethicallyacceptable justification;

4) provide that all confidentiality and publication clauses:

(a) be consistent with the researcher’s duty to share new information fromclinical trials with REBs and trial participants in a timely manner(Section D);

(b) be reasonable in terms of any limitations or restrictions on thepublication or other dissemination or communication of information;

(c) permit principal investigators to access all trial data;

(d) permit researchers to access all trial data collected at their respectivesites; and

(e) permit all researchers to access all trial data in cases where no principalinvestigator is named.

In the interests of transparency and accountability, it is necessary for researchersto have access to trial data. Normally, it is the responsibility of the named PI toexamine the entire trial data set and to ensure that data are not inappropriatelyexcluded from analyses and disseminations of findings. If a PI is not named toavoid sharing the entire data set of a multi-site trial, this would be contrary toethical clinical trial reporting in accordance with TCPS 2. To promote transparencyand accountability, TCPS 2 requires that, in the absence of a named PI, all siteresearchers shall be entitled to access the entire data set.

Review of ethical aspects of researcher-sponsor contracts should be undertaken byan REB, or by or under the auspices of another competent institutional authorityas an integral part of the research ethics review process. If done under the latter


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process, the review of contracts should be conducted in a manner that: (1) conformsto the special ethical duties, mandate and purposes of REB review; and (2) consultswith the REB when necessary.

In the review process, the onus to justify restrictions on dissemination or access todata should lie with the one seeking such restriction, usually the researcher orsponsor. The reasonableness of restrictions on either the content or timing ofdissemination should be measured against the written institutional policies. Forexample, some existing institutional policies deem unacceptable any publicationrestrictions that exceed a time limit of three to six months after the close of thetrial. Such policies should also address restrictions on the dissemination ofparticular kinds of information, such as information that may be consideredproprietary or trade secrets. Restrictions on information that participants wouldreasonably consider relevant to their welfare (see Articles 11.7 and 11.8), or thatare required to give appropriate context to a manuscript or other publication, areseldom, if ever, justified.

Endnotes

1 These conditions are drawn from the recommendations of the Final Report of the National PlaceboWorking Committee on the Appropriate Use of Placebos in Clinical Trials in Canada (July 2004), withminor amendments approved by the Canadian Institutes of Health Research (CIHR) Standing Committeeon Ethics.

2 World Health Organizations standards, International Clinical Trials Registry Platform.

3 International Committee of Medical Journal Editors, Sponsorship, Authorship, and Accountability(August 2007).

4 CONSORT Statement: (accessed April 19, 2010).

References

• Canada. Food and Drugs Act. Natural Health Products Regulations, Part 4: Clinical TrialsInvolving Human Subjects (SOR/2003-196) 5 June 2003.

• Canadian Institutes of Health Research. “Open Access Policy” (January 2013).

• Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council ofCanada, Social Sciences and Humanities Research Council of Canada, Access to Research Results:Guiding Principles.

• Consolidated Standards of Reporting Trials: CONSORT Statement, and Explanation and Elaborationdocument.


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• Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Beingwith regard to the Application of Biology and Medicine: Convention on Human Rights andBiomedicine. 1997.

• Council for International Organizations of Medical Sciences (CIOMS). International EthicalGuidelines for Biomedical Research Involving Human Subjects. Geneva: 2002.

• Health Canada. Therapeutic Products Directorate. Medical Devices Bureau. Guidance documents.

• International Conference on Harmonisation. Guidance for Industry: Good Clinical Practice –Consolidated Guidelines, ICH Topic E6: Technical Requirements for the Registration ofPharmaceuticals for Human Use. 1996. Adopted by Health Canada in 1997.

• Ottawa Hospital Research Institute. Ottawa Statement on Trial Registration.

• United States. Food and Drug Administration. Food and Drug Administration Amendments Act of2007. September 2007.

• United States. National Institutes of Health. NIH Policy for Data and Safety Monitoring. Released1998.

• ———. Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials. Released2000.

• World Medical Association. Declaration of Helsinki – Ethical Principles of Medical ResearchInvolving Human Subjects. 2008.


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Chapter 12HUMAN BIOLOGICAL MATERIALS INCLUDING MATERIALS RELATED TO

HUMAN REPRODUCTION

Introduction

The use of materials originating from human bodies for research contributes greatly to the ad-vancement of knowledge. The sources of these materials can be from patients following diagnosticor therapeutic procedures, autopsy specimens, donations of organs or tissue from living or deadhumans, body wastes (including urine, saliva, sweat) or abandoned tissue. Biological materialsmay also be sought from individuals for use in a specific research project. Once collected, biolog-ical materials may be held in biobanks to serve as a research resource for many years.

Ethical considerations raised by research involving human biological materials centre on accept-able access to, and use of, the materials, potential privacy concerns arising from the handling ofinformation derived from such materials, and the special status some individuals and groups accordto the human body and its parts. Because the significance of biological materials varies among in-dividuals and groups, it is important to assess the ethics of research involving such materials withan awareness of and sensitivity to the known values, beliefs and attitudes of those from whom thematerials originated.

Sections A to D of this chapter provide guidance on research involving human biological materials.For the purposes of this Policy, human biological materials include tissues, organs, blood, plasma,skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva and other body fluids.Section E addresses research involving the subset of biological materials that are related to humanreproduction. Section F addresses research involving the subset of human biological materialsknown as human pluripotent stem cells.

As noted in Chapter 2, an individual whose data and/or biological materials are used in researchbecomes a participant. In regard to human biological materials, individuals may become partici-pants by agreeing to provide a biological sample for use in a particular project. Individuals mayalso choose to donate organs, tissue or their entire body for research that occurs after their death.In this way, they become participants through their donation. Researchers may seek access tohuman biological materials for secondary use in research and, in accordance with Section C ofthis chapter, a research ethics board (REB) may waive a requirement for individual consent.

A. Key Concepts

Identifiable Human Biological Materials

Human biological materials that may reasonably be expected to identify an individual, alone or incombination with other available information, are considered identifiable biological materials for

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the purposes of this Policy. Identifiability of human biological materials has to be assessed relativeto the current state of science and the availability of other sources of identifying information aboutparticipants and increasingly sophisticated methods of re-identification. The assessment of whetherhuman biological materials are identifiable is made in the context of a specific research project.

Types of Human Biological MaterialsThe following categories, similar to those found in Chapter 5 in regard to categories of information,provide guidance for assessing the extent to which human biological materials could be used toidentify an individual:

• Identified human biological materials – the materials are labelled with a direct identifier(e.g., name, personal health number). Materials and any associated information aredirectly traceable back to a specific individual.

• Coded human biological materials – direct identifiers are removed from the materialsand replaced with a code. Depending on access to the code, it may be possible to re-identify specific individuals (e.g., a principal investigator retains a key that links thecoded material with a specific individual if re-linkage is necessary).

• Anonymized human biological materials – the materials are irrevocably stripped of directidentifiers, a code is not kept to allow future re-linkage, and risk of re-identification ofindividuals from remaining indirect identifiers is low or very low.

• Anonymous human biological materials – the materials never had identifiers attachedto them and risk of identification of individuals is low or very low.

Due to continuing technological development in genetics, individuals with access to stored humanbiological materials are increasingly able to use genetic markers to link a non-identifiable samplewith an identified sample. For this reason, genetic analysis has made it more difficult to categorizehuman biological materials as anonymous or anonymized. The definitions above relate toidentification of individuals; however, some research involving human biological materials,especially genetic research, may involve identification of groups, even though the human biologicalmaterials are non-identifiable at an individual level. Researchers and REBs should be aware of,and guard against, threats to individual privacy and autonomy that arise from re-identificationrisks, as well as risks to groups, particularly where sensitive research findings will be linked tospecific groups.

To maintain confidentiality, it may seem desirable to use anonymized or anonymous humanbiological materials. However, the scientific requirements of many studies may necessitate use ofidentifiable human biological materials, to link materials with information about participants, andto avoid using different samples from the same individual. Use of anonymized or anonymoushuman biological materials has the disadvantage of making it impossible to offer the benefits ofresearch findings to participants and their families, or to alert them to relevant clinical findings.This is particularly significant when research may disclose a previously undiagnosed condition,such as HIV infection or an inherited predisposition to breast cancer, for which potentially effectivetreatments are available. Use of non-identifiable human biological materials also precludeswithdrawal of a participant’s material from research use, even at the participant’s request.

Chapter 12 – Human Biological Materials Including Materials Related to Human Reproduction

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B. Collection of Human Biological MaterialsHuman biological materials may be obtained in different ways:

1. they may be collected expressly for a specific research purpose;

2. they may be collected incidentally to medical or diagnostic procedures with no initialintent to be used in research; or

3. they may be collected for research or medical or diagnostic purposes with someexpectation that they may, or will, also be used in future research, although the preciseresearch project(s) may not be known at the time.

The first category above refers to the initial collection of human biological materials for research,which is described in this section. The latter two categories are relevant to subsequent, secondaryuses of human biological materials for research that may not have been conceived at the time thetissue was taken. Secondary use of biological materials is described in Section C.

Article 12.1 Research involving collection and use of human biological materials requires REBreview and:

(a) consent of the participant who will donate biological materials; or

(b) consent of an authorized third party on behalf of a participant who lacksdecision-making capacity, taking into account any research directive thatapplies to the participant; or

(c) consent of a deceased participant through a donation decision made prior todeath, or by an authorized third party.

Application Article 12.1 applies prospectively, that is, prior to the collection of human biologicalmaterials for research purposes. It applies the general elements of consent inChapter 3 to the collection and use of human biological materials. During theconsent process, a clear distinction should be made between consent to researchparticipation and consent for any clinical procedure or test. In practice, this maymean separate consent information and forms, but in any event the different usesmust be clearly explained. Individuals who do not wish to contribute humanbiological materials for research are free to withhold consent without penalty, andwithout prejudicing access to any treatment they would otherwise receive. Forindividuals who lack decision-making capacity, the guidance developed in Chapter3 regarding authorized third parties shall be observed.

Where a participant has expressed preferences for future research participation ina research directive before losing decision-making capacity, researchers andauthorized third parties shall take such directives into account during the consentprocess. Chapter 3 provides guidance on research directives. REBs and researchersshould be aware that provincial human tissue gift laws may provide a legalframework for the donation of tissue upon death.


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Article 12.2 To seek consent for use of human biological materials in research, researchers shallprovide to prospective participants or authorized third parties, applicableinformation as set out in Article 3.2 as well as the following details:(a) the type and amount of biological materials to be taken;

(b) the manner in which biological materials will be taken, and the safety andinvasiveness of the procedures for acquisition;

(c) the intended uses of the biological materials, including any commercial use;

(d) the measures employed to protect the privacy of and minimize risks toparticipants;

(e) the length of time the biological materials will be kept, how they will bepreserved, location of storage (e.g., in Canada, outside Canada), and processfor disposal, if applicable;

(f) any anticipated linkage of biological materials with information about theparticipant; and

(g) the researchers’ plan for handling results and findings, including clinicallyrelevant information and incidental findings.

Application Chapter 3, especially Article 3.2, provides detailed guidance on the need for consentto participation in research. Article 12.2 provides additional guidance oninformation that prospective participants generally require to make an informeddecision to donate biological materials for use in research. While all the basicguidelines of Chapter 3 regarding consent apply to research involving humanbiological materials, some deserve special attention. For example, explaining thepotential for commercialization or financial conflict of interest is important, assome research with human biological materials may involve the possibility ofsignificant commercial gain for researchers or sponsors. The process for requestingwithdrawal of human biological materials from research shall also be clearlyexplained, along with an explanation of the conditions under which researcherswould not be able to remove a participant’s data from the project. For instance,where participants request the withdrawal of their biological materials, informationalready derived from the materials and aggregated into findings cannot bewithdrawn. Anonymization of human biological materials may also precludesubsequent withdrawal. Chapter 3 provides further guidance on handling incidentalfindings.

C. Consent and Secondary Use of Identifiable Human Biological Materials for Research Purposes

Chapter 5 provides detailed guidance on secondary use of information for research purposes (inparticular, see Articles 5.5A, 5.5B and 5.6). The following section adapts the provisions in Chapter5 to the specific context of research involving secondary use of human biological materials. As


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researchers who seek to use human biological materials for research will often also seek access toinformation about individuals from whom the materials originate, this section and Chapter 5 shouldbe read together.

Secondary use refers to the use in research of human biological materials originally collected fora purpose other than the current research purpose. A researcher may seek to use human biologicalmaterials left over from a diagnostic examination or surgical procedure, or materials that werecollected for an earlier project. Reasons to conduct secondary analyses include: avoidance ofduplication in primary collection and the associated reduction of burdens on participants;corroboration or criticism of the conclusions of the original research; comparison of change in aresearch sample over time; application of new tests of hypotheses that were not available at thetime of original collection; and confirmation that the data or materials are authentic. Privacyconcerns and questions about the need to seek consent arise, however, when human biologicalmaterials provided for secondary use in research can be linked to individuals, and when thepossibility exists that individuals can be identified in published reports, or through linkage ofhuman biological materials with other data (Article 5.7).

Article 12.3A Researchers who have not obtained consent from participants for secondary useof identifiable human biological materials shall only use such material for thesepurposes if they have satisfied the REB that:

(a) identifiable human biological materials are essential to the research;

(b) the use of identifiable human biological materials without the participant’sconsent is unlikely to adversely affect the welfare of individuals from whomthe materials were collected;

(c) the researchers will take appropriate measures to protect the privacy ofindividuals and to safeguard the identifiable human biological materials;

(d) the researchers will comply with any known preferences previously expressedby individuals about any use of their biological materials;

(e) it is impossible or impracticable to seek consent from individuals from whomthe materials were collected; and

(f) the researchers have obtained any other necessary permission for secondaryuse of human biological materials for research purposes.

If a researcher satisfies all the conditions in Article 12.3A(a) to (f), the REB mayapprove the research without requiring consent from the individuals from whomthe biological materials were collected.

Application In the case of the secondary use of identifiable human biological materials,researchers must obtain consent unless the researcher satisfies all the requirementsin Article 12.3A.


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The exception to the requirement to seek consent in this article is specific tosecondary use of identifiable human biological materials. The terms of Article 3.7Aaddress alteration of consent in other circumstances and do not apply here.

Secondary use of human biological materials identifiable as originating from aspecific Aboriginal community, or a segment of the Aboriginal community at large,is addressed in Articles 9.20 to 9.22.1

“Impracticable” refers to undue hardship or onerousness that jeopardizes theconduct of the research; it does not mean mere inconvenience.2 Consent may beimpossible or impracticable when the group is very large or its members are likelyto be deceased, geographically dispersed or difficult to track. Attempting to trackand contact members of the group may raise additional privacy concerns. Financial,human and other resources required to contact individuals and seek consent mayimpose undue hardship on the researcher. In some jurisdictions, privacy laws maypreclude researchers from using personal information to contact individuals to seektheir consent for secondary use of information.

At the time of initial collection, individuals may have had an opportunity to expresspreferences about future uses of their biological materials, including research uses(see paragraphs (d) and (i) in the Application of Article 3.2). Custodians that holdhuman biological materials have an obligation to respect the individual’s expressedpreferences. Where an individual does not want biological materials used for futureresearch, custodians should remove these biological materials from any collectionsused or made available for research. Alternatively, individuals may have made anexpress donation of biological materials for research in accordance with humantissue gift legislation.

In cases where the proposed research involves issues of greater sensitivity (e.g., re-search involving stigmatizing conditions), an REB may require that researchersengage in discussion with people whose perspectives can help identify the ethicalimplications of the research, and suggest ways to minimize any associated risks.Discussion is not intended to serve as proxy consent. Rather, a goal of discussionis to seek input regarding the proposed research, such as the design of the research,measures for privacy protection, and potential uses of findings. Discussion mayalso be useful to determine whether the research will adversely affect the welfareof individuals from whom the biological materials were collected. Researchers shalladvise the REB of the outcome of such discussions. The REB may require modifi-cations to the research proposal based on these discussions.

Article 12.3B Researchers shall seek REB review, but are not required to seek participantconsent, for research that relies exclusively on the secondary use of non-identifiable human biological materials.

Application The onus will be on the researcher to establish to the satisfaction of the REB that,in the context of the proposed research, the human biological materials to be usedcan be considered non-identifiable for all practical purposes. For example, the


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secondary use of coded human biological materials may identify individuals inresearch projects where the researcher has access to the key that links theparticipants’ codes with their names. Consent would be required in this situation.However, the same coded human biological materials may be assessed as non-identifiable in research projects where the researcher does not have access to thekey. Consent would not be required in this situation.

Article 12.4 When secondary use of identifiable human biological materials without therequirement to seek consent has been approved under Article 12.3A, researchers whopropose to contact individuals for additional biological materials or information shall,prior to contact, seek REB approval of the plan for making contact.

Application In certain cases, a research goal may be achieved only through follow-up contactwith individuals to collect additional biological materials or information. UnderArticle 12.3A, the REB may have approved secondary use without the requirementto seek consent based, in part, on the impossibility or impracticability of seekingconsent from all individuals whose biological materials are proposed for use inresearch. Where contact with a sub-group is feasible, researchers may subsequentlywish to attempt to make contact with some individuals to obtain additionalinformation or biological materials. Contact with individuals whose previouslycollected biological materials have been approved for secondary use in researchraises privacy concerns. Individuals might not want to be contacted by researchersor might be upset that identifiable biological materials were disclosed to researcherswithout their consent. The potential benefits of follow-up contact must clearlyoutweigh the risks to individuals of follow-up contact, and the REB must besatisfied that the proposed manner of follow-up contact minimizes risks toindividuals. The proposed plan should explain who will contact individuals to invitetheir participation in the research (e.g., a representative of the organization thatholds the individual’s biological materials) and the nature of their relationship withthose individuals. Researchers must also ensure that a plan for follow-up contactcomplies with applicable privacy legislation; for example, some privacy lawsprohibit researchers from contacting individuals unless the custodian of theinformation has first obtained individuals’ consent to be contacted. Wheneverpossible, it is preferable that re-contact with participants be carried out by theorganization or the custodian holding the biological materials. Researchers willneed to seek consent from individual participants for any new collection of data orbiological materials. Article 3.1 provides further guidance on consent andapproaches to recruitment.

D. Storage and Banking of Human Biological Materials

The collection and retention of human biological materials in biobanks creates an ongoing resourcefor research. Biobanks vary widely in their characteristics: some are very small, while others holdbiological materials from thousands of individuals; they may be disease-specific or containmaterials from a wide population base. Different types of human biological materials may be


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stored in biobanks, such as blood, tumour or tissue samples. Biobanks may include, or be linkedwith, databases of identifiable or non-identifiable information. Materials held in a biobank maybe intended only for use in a specific project, or a biobank may be established to provide accessto biological materials for numerous projects over many years. Researchers engaged in multi-siteresearch may seek access to materials held in biobanks in different jurisdictions (see Chapter 8for additional guidance).

Biobanking facilitates research with human biological materials and offers potential benefits tosociety. Access to stored human biological materials – and associated information about individualswhose materials are banked – can be particularly useful in helping researchers understand diseasesthat result from complex interactions between our genetic makeup, environmental exposure andlifestyles. Banking of human biological materials may also present risks to individuals whosebiological materials and other personal information are stored, accessed, used, retained anddisclosed through a biobank. Research involving such materials may also implicate the interestsof biological relatives and others with shared genetic characteristics.

Article 12.5 Institutions and researchers that maintain biobanks:

(a) shall ensure that they have or use appropriate facilities, equipment, policies andprocedures to store human biological materials safely, and in accordance withapplicable standards; and

(b) shall establish appropriate physical, administrative and technical safeguards toprotect human biological materials and any information about participants fromunauthorized handling.

Application Safe storage of human biological materials is important to maintain their scientificvalue, and to protect materials and associated information about participants.Procedures for storage and record keeping shall include effective measures toensure that participants’ identities are protected. Such measures include the securityof facilities and effective procedures for data handling, record keeping andregulating access to human biological materials and information. Appropriategovernance of biobanks is also important for managing access to and use of storedbiological materials. The appropriate governance structure and management of abiobank will vary depending on its size and usage.

Organizations that maintain biobanks may have their own policies on privacy of,confidentiality of and access to materials. Researchers should be aware ofrequirements for compliance with such policies. For example, researchers may berequired to apply to the organization for permission to access biological samples,and they may be required to enter into an agreement with the organization that setsout conditions for research access and use of materials in the biobank.

Identifiable data derived from human biological materials may be linked to otherresearch or public databases. Such data linking can be a powerful research tool anda valuable resource for monitoring the health of populations, understanding factors


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influencing disease, and evaluating health services and interventions. However, datalinkage also raises separate privacy issues, discussed in Section E of Chapter 5.

E. Research Involving Materials Related to Human Reproduction

Researchers who conduct research involving human biological materials related to humanreproduction shall follow applicable guidance expressed in other chapters of this Policy. Thissection provides further guidance for research involving embryos, fetuses, fetal tissue, andreproductive materials. For the purposes of this Policy the following definitions apply:3

• Embryo means a human organism during the first 56 days of its development followingfertilization or creation, excluding any time during which its development has beensuspended, and includes any cell derived from such an organism that is used for the purposeof creating a human being.

• Fetus means a human organism during the period of its development beginning on the 57thday following fertilization or creation, excluding any time during which its development hasbeen suspended, and ending at birth.

• Fetal tissue includes membranes, placenta, umbilical cord, amniotic fluid and other tissuethat contains genetic information about the fetus.

• Human reproductive materials means a sperm, ovum or other human cell, or a human gene,and includes a part of any of them.

While research involving materials related to human reproduction has great promise for assistingthe development of healthy pregnancies, curing illness, and repairing or rebuilding tissue, it raisesspecial ethical considerations. Accordingly, this research has provoked vigorous debate. Discussionand reflection should continue as our scientific understanding develops.

Significant ethical issues include consent to research involving materials related to humanreproduction, privacy concerns, the risk of harm to those who provide reproductive materials, anembryo or fetus, and potential commodification of reproductive capabilities and materials relatedto reproduction. Researchers and REBs have a continuing duty to remain mindful of the publicinterest in these issues, and to respect policy, legal and regulatory requirements. In particular,researchers and REBs shall be aware of the detailed requirements and prohibitions set out in theAssisted Human Reproduction Act.

Article 12.6 In addition to requirements in this chapter that apply to all research involvinghuman biological materials, the following guidelines apply to research involvingmaterials related to human reproduction:

(a) Research using materials related to human reproduction in the context of ananticipated or ongoing pregnancy shall not be undertaken if the knowledgesought can reasonably be obtained by alternative methods.


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(b) Materials related to human reproduction for research use shall not be obtainedthrough commercial transaction, including exchange for services.

Application Because of the risk of harm to the woman or the fetus, Article 12.6(a) requires thatthe use of these materials be avoided where pregnancy is anticipated or ongoing,if research goals may be accomplished in some other way.

Article 12.6(b) reflects concerns about the commercialization or commodificationof human reproduction. Exchange for services refers, for instance, to trading aservice, such as a medical treatment, for an in vitro embryo or gamete.

Research Involving Human Embryos

Article 12.7 Research on in vitro embryos already created and intended for implantation toachieve pregnancy is acceptable if:

(a) the research is intended to benefit the embryo;

(b) research interventions will not compromise the care of the woman, or thesubsequent fetus;

(c) researchers closely monitor the safety and comfort of the woman and the safetyof the embryo; and

(d) consent was provided by the gamete donors.

Application Research potentially altering the embryo by chemical or physical manipulationshall be distinguished from research directed at ensuring normal fetal development.For example, the evaluation of potential teratogens and their effects on certain celllineages may use early embryos, but those embryos must not be implanted for anongoing pregnancy.

The Assisted Human Reproduction Act prohibits the creation of a human embryospecifically for research purposes, with the limited exception of creating an embryofor the purpose of improving, or providing instruction in, assisted reproductionprocedures.

Article 12.8 Research involving embryos that have been created for reproductive or otherpurposes permitted under the Assisted Human Reproduction Act, but are no longerrequired for these purposes, may be ethically acceptable if:

(a) the ova and sperm from which they are formed were obtained in accordancewith Article 12.7;

(b) consent was provided by the gamete donors;

(c) embryos exposed to manipulations not directed specifically to their ongoingnormal development will not be transferred for continuing pregnancy; and


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(d) research involving embryos will take place only during the first 14 days aftertheir formation by combination of the gametes, excluding any time duringwhich embryonic development has been suspended.

Application Research on embryos requires the consent of the gamete donors. The REB may notwaive the requirement for such consent. In particular, researchers and REBs shouldbe aware of the Assisted Human Reproduction (Section 8 Consent) Regulationsunder the Assisted Human Reproduction Act.4

Research Involving Fetuses and Fetal Tissue

Article 12.9 Research involving a fetus or fetal tissue:

(a) requires the consent of the woman; and

(b) shall not compromise the woman’s ability to make decisions regarding contin-uation of her pregnancy.

Application Research may be undertaken on methods to treat, in utero, a fetus with genetic orcongenital disorders. Because the fetus and the woman cannot be treated separately,any intervention to one involves an intervention to the other. Research involving afetus or fetal tissue shall be guided by respect for the woman’s autonomy andphysical integrity. Guidance provided in other chapters of this Policy (e.g., consent,privacy and confidentiality, inclusion and exclusion) will also apply. Researchersshould ensure that a clear distinction is made between consent to research andconsent for any clinical procedures or testing. In practice, this may mean separateconsent information and documents, but regardless of the process employed, thedifferences between research and clinical procedures must be clearly explained.

Where the fetus has been born alive and viable, research involving humanbiological materials associated with the child must meet the conditions of Article3.9. A fetus that has been born alive and viable is a child with its own independentinterests.

F. Research Involving Human Pluripotent Stem Cells

Guidance regarding a proportionate approach to research ethics review, consent, privacy,confidentiality, and research with human biological materials and other ethical guidance describedin earlier chapters of this Policy apply equally to research involving human pluripotent stem cells.This section provides further guidance for research involving human pluripotent stem cells. Inaddition to following the guidance provided in this Policy, researchers are responsible forcompliance with all applicable legal and regulatory requirements, e.g., the Assisted HumanReproduction Act and its Regulations and the Food and Drugs Act and its Regulations.

Stem Cell Oversight Committee (SCOC)In recognition of the complex ethical issues associated with research involving pluripotent stem


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cells, a Stem Cell Oversight Committee (SCOC) was created by CIHR in 2003. SCOC reviewsresearch involving human pluripotent stem cells that:

• have been derived from an embryonic source; and/or

• will be transferred into humans or non-human animals

to ensure compliance with Chapter 12, Section F of this Policy. Applications that receive SCOCapproval shall then be submitted to local REBs as part of the local research ethics review process.SCOC does not review research involving human pluripotent stem cells that come from somatic(non-embryonic) tissue and that are not going to be transferred into humans or non-human animals.

Article 12.10 Research involving human pluripotent stem cells that have been derived from anembryonic source and/or that will be grafted or transferred in any other form intohumans or non-human animals requires review and approval by SCOC and an REB.The researcher shall provide evidence of SCOC approval to the REB.

Application 1) Research Conforming to this Policy and Requiring SCOC Review

Types of stem cell research that conform to this Policy and require SCOC reviewinclude:

(a) Research for the purpose of deriving or studying human embryonic stem celllines or other cell lines of a pluripotent nature from human embryos, providedthat:

(i) the embryos used, whether fresh or frozen, were originally created for reproductive purposes and are no longer required for such purposes; and

(ii) consent was provided by the persons for whom the embryos were originallycreated for reproductive purposes. Where third party donor gametes were used to create the embryo, the third party gamete donor(s) shall have given, at the time of donation, consent to the unrestricted research use of any embryos created, when these embryos are no longer required for reproductive purposes. Where the third party gamete donors referred to in this paragraph are anonymous, it is not possible to seek their consent for embryo use. In such cases, the responsibility of consent for embryo use has, in effect, been transferred to the persons for whom the embryos were created for reproductive purposes; and

(iii) neither the ova nor the sperm from which the embryos were created, nor the embryos themselves, were obtained through commercial transactions (i.e., were acquired by payment of money in excess of costs actually incurred, or in exchange for services).

(b) Research on anonymized or coded human embryonic stem cell lines that havebeen created in Canada, or created elsewhere and imported for researchpurposes, provided that:


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(i) those created in Canada were developed in compliance with this Policy or, prior to December 9, 2014, the Guidelines for Human Pluripotent StemCell Research. It is incumbent on the recipient of such cell lines to ensurethat this is the case. The recipient shall provide satisfactory evidence to SCOC and the local REB that the cell lines fulfill the consent provisions before research can begin;

(ii) the recipient of stem cell lines created in a country other than Canada provides SCOC with satisfactory evidence that the manner in which the stem cell lines were created in the country of origin, including the embryo donors' consent, satisfies the laws and policies of that country. Should SCOC find that the manner of creation of these stem cell lines and the consent provisions vary significantly from the principles of this Policy, or, prior to December 9, 2014, the Guidelines for Human Pluripotent Stem Cell Research, it may not approve the use of these cell lines in stem cell research in Canada.

(c) Research involving the grafting or any other form of transfer of human embryonicstem cells, embryonic germ cells, induced pluripotent stem cells, cells derivedfrom those cells, or other human cells that are likely to be pluripotent into non-human animals, from birth to adulthood, provided that:

(i) the research is designed to reconstitute a specific tissue or organ to derive a pre-clinical model or to demonstrate that the cells are pluripotent (e.g., teratoma formation); and

(ii) these non-human animals grafted with human stem cells will not be used for reproductive purposes.

(d) Research involving the grafting or any other form of transfer of human embryonicstem cells, embryonic germ cells, induced pluripotent stem cells, cells derivedfrom those cells, or other human cells that are likely to be pluripotent into humanswith legal capacity shall be in compliance with the Food and Drugs Act and itsRegulations, including the Safety of Human Cells, Tissues and Organs forTransplantation Regulations.

2) Research Not Conforming to this Policy

The following types of stem cell research do not conform to this Policy:

(a) Research involving the creation of human embryos specifically to derive stemcell lines or other cell lines of a pluripotent nature;

(b) Research involving somatic cell nuclear transfer into human oocytes (cloning)or involving stimulation of an unfertilized egg to produce a human embryo(parthenogenesis) for the purposes of developing human embryonic stem celllines or other cell lines of a pluripotent nature;


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(c) Research involving the directed donation of human embryos or humanembryonic stem cell lines to particular individuals;

(d) Research in which human or non-human embryonic stem cells, embryonic germcells, induced pluripotent stem cells, or other cells that are likely to bepluripotent are combined with a human embryo;

(e) Research in which human or non-human embryonic stem cells, embryonic germcells, induced pluripotent stem cells, or other cells that are likely to bepluripotent are grafted or transferred in any other form to a human fetus;

(f) Research in which human embryonic stem cells, embryonic germ cells, inducedpluripotent stem cells, or other cells that are likely to be pluripotent arecombined with a non-human embryo; or

(g) Research in which human embryonic stem cells, embryonic germ cells, inducedpluripotent stem cells, or other cells that are likely to be pluripotent are graftedor transferred in any other form to a non-human fetus.

Consent

Chapter 3, especially Articles 3.1 to 3.5, provides detailed guidance on the need to seek consentfor participation in research. The following articles provide additional guidance for situations thatare unique to stem cell research.

Article 12.11 Embryos no longer needed for reproductive purposes may be donated for use inresearch (including research to derive and study human embryonic stem cells).Embryo donors and gamete donors, if these are different individuals, shall beadvised of all available options in respect of the use of the embryos and theirconsent sought prior to the use.

Article 12.12 At the time when the embryos are to be used for research to derive and studyembryonic stem cells (and other human cells or cell lines of a pluripotent nature),consent of the embryo donors shall be sought again. Research shall not proceedunless consent is obtained.

Application This requirement affirms the right of the donors to withdraw consent and isnecessary because of the possible lengthy delay between the time at which theoriginal consent is given and the time at which the embryos are utilized for researchpurposes. Members of the health care team treating and/or counselling prospectiveparticipants should not be the persons to seek consent from the embryo donors atthe time of re-consent. A renewal of the consent provided by the gamete donors (ifthe gamete donors are not the same individuals as the embryo donors), is notrequired provided that appropriate consent for the unrestricted research use of theembryos was given at the time of gamete donation.


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Article 12.13 When seeking consent for human embryonic stem cell research, in addition to theinformation outlined in Article 3.2 researchers shall provide to prospective researchparticipants the following:

(a) An explanation that the cell line(s) will be anonymized or coded;

(b) An assurance that prospective research participants are free to not participateand have the right to withdraw at any time before an anonymized or coded cellline is created;

(c) An explanation that the research could result in the production of a stem cellline that could be maintained for many years, distributed to other parts of theworld, and used for various research purposes;

(d) An explanation that the research participants will not benefit directly financiallyfrom any future commercialization of cell lines; nor will there be any personalbenefit in terms of dispositional authority over any embryonic cell lines created(i.e., there will be no directed donation of the cells or cell lines to particularindividuals).

Application Article 12.13(b) refers to the withdrawal of both consent and human biologicalmaterials. Once an anonymized or coded cell line is created, it may have a widedistribution, making withdrawal of materials almost impossible.

Creation of Excess Embryos

Article 12.14 Researchers shall not ask, encourage, induce or coerce members of the health careteam to generate more embryos than necessary for the optimum chance ofreproductive success. This is tantamount to creating embryos for research, whichis prohibited under the Assisted Human Reproduction Act.

National Registry

SCOC maintains an electronically accessible national registry of human pluripotent stem cell linesderived from an embryonic source, generated in Canada. Induced human pluripotent stem celllines are not listed with the registry, as they are not derived from embryonic sources.

Article 12.15 All human pluripotent stem cell lines derived directly from embryos under theauspices of an institution that is eligible to receive Agency funds shall be listedwith the national registry of human embryonic stem cell lines and made availableby the researcher to other researchers, subject to reasonable cost-recovery charges.

Privacy and Confidentiality

The secondary use of human biological materials for research purposes must meet the requirementsof Articles 12.3A and 12.4 that provide detailed guidance on protecting personal information ofparticipants. The following articles provide additional guidance for situations that are unique to


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stem cell research. In these cases, all human cells or cell lines should be delivered in an anonymizedor coded form and, if coded, the key code should be accessible only to a custodian or trusted thirdparty who is independent of the researcher who receives the cells (see Chapter 5, Section A, Typesof Information).

Article 12.16 All human pluripotent stem cell lines shall be anonymized or coded unless theresearch only involves the directed donation of induced pluripotent stem cells.

Application While research involving the directed donation of human embryonic stem cell linesis not permitted under this Policy (Article 12.10.2[c]), research involving thedirected donation of induced pluripotent stem cells is permitted, as inducedpluripotent stem cells are not derived from human embryos.

Article 12.17All researchers who make stem cell lines available to other academics shall ensurethat the cell lines are anonymized or coded.

Conflicts of Interest

Chapter 7 (in particular Articles 7.2 and 7.4) provides guidance on conflicts of interest. Thefollowing articles provide additional guidance for situations that are unique to stem cell research.

Article 12.18 Stem cell research teams shall not include members of the health care team treatingand/or counselling prospective participants who could influence the prospectiveparticipants’ decisions to donate their embryos.

Application This article seeks to minimize the risk that, for the purposes of stem cell research,women will feel pressured to create more embryos than needed for reproductivepurposes or be pressured to donate embryos no longer needed for reproductivepurposes. There may be a risk of undue influence where health care team membersare also members of the stem cell research team (see Article 3.1).

Article 12.19 When researchers or their institutions have, or acquire, financial interests in theoutcome of the stem cell research including, but not limited to, income fromcommercial firms supporting their research, stock holdings in corporationssupporting their research, or patents in products produced through their research,they shall disclose this information to SCOC, the REB and current and prospectiveresearch participants (see Articles 7.2 and 7.4 regarding institution and researcherconflicts of interest). In some instances, disclosure may not be a sufficient responseto concerns about actual, perceived or potential conflicts of interest. Researchersand/or their institutions may be asked to remedy any possible distortion of properprocedures attributable to such conflicts.

Article 12.20 Copies of contracts between researchers, institutions and industry sponsors and anyrelevant budgetary information shall be provided to SCOC and the REB to examineand evaluate any potential or actual conflicts of interest and to ensure the right topublish in a timely manner without undue restriction.


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Endnotes

1 See also Canadian Institutes of Health Research, CIHR Guidelines for Health Research InvolvingAboriginal People. 2 For discussion of factors relevant to assessing impracticability of consent, see, for example, CanadianInstitutes of Health Research, CIHR Best Practices for Protecting Privacy in Health Research, Section3.3, Secondary Use (September 2005). 3 The definitions of embryo, fetus and human reproductive materials are taken from the Assisted HumanReproduction Act (2004, c. 2).4 Assisted Human Reproduction (Section 8 Consent) Regulations (SOR/2007-137).

References

• International Conference on Harmonisation of Technical Requirements for the Registration ofPharmaceuticals for Human Use (ICH) defines biological sample coding categories. Health Canadahas adopted these definitions.

• Organisation for Economic Co-operation and Development. (OECD), Guidelines for HumanBiobanks and Genetic Research Databases. 2009.

• Québec. Fonds de la recherche en santé du Québec. Final Report: Advisory Group on a GovernanceFramework for Data Banks and Biobanks Used for Health Research. 2006.


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Chapter 13HUMAN GENETIC RESEARCH

Introduction

Human genetic research involves the study of genetic factors responsible for human traits and theinteraction of those factors with each other, and with the environment. Research in this areaincludes the identification of genes that comprise: the human genome; functions of genes; thecharacterization of normal and disease conditions in individuals, biological relatives, families,communities and groups; and studies involving gene therapy. Participants in clinical trials areincreasingly being asked to participate in genetic studies in addition to the primary clinical trial.With the growth of genetic research, especially whole-genome research, researchers, researchethics boards (REBs) and participants should be aware of the ethical issues that this research raises.

Genetic research may have profound social impacts, both positive and negative. As geneticresearch advances, genes and their alleles (versions) are being identified, but the function of eachgene and its relationship to disease conditions, or other characteristics may not be clear. In single-gene disorders, for example, an allele of a single gene is directly related to a hereditary disease.More commonly, diseases or personal characteristics are influenced by multiple genes, as well asenvironmental factors.

Research may help us better understand the human genome, and genetic contributions to healthand disease. It may lead to new approaches to preventing and treating disease. Individuals maybenefit from learning about their genetic predispositions, if intervention strategies are available toprevent or minimize disease onset and mitigate symptoms, or to otherwise promote health. Geneticresearch also has the potential, however, to stigmatize individuals, communities or groups, whomay experience discrimination or other harms because of their genetic status, or may be treatedunfairly or inequitably.

A. Application of Core Principles to Genetic Research

Genetic information has implications beyond the individual because it may reveal informationabout biological relatives and others with whom the individual shares genetic ancestry. Theparticipation of an individual in genetic research may therefore have ramifications for these otherpersons, communities or groups. In some cases, researchers specifically seek to conduct geneticresearch with members of families, communities or groups that requires particular attention to thesocial and cultural contexts in which participants live. Research with families, communities orgroups may raise special considerations regarding recruitment of participants, consent processes,privacy and confidentiality.

Chapter 13 – Human Genetic Research

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Article 13.1 Guidance regarding a proportionate approach to research ethics review, consent,privacy, confidentiality, research with human biological materials and other ethicalguidance described in earlier chapters of this Policy apply equally to human geneticresearch.

Application In developing and reviewing proposals involving genetic research, researchers andREBs should refer to earlier chapters in this Policy, including consent in Chapter 3,privacy and confidentiality in Chapter 5, and human biological materials and mate-rials related to human reproduction in Chapter 12. Other chapters relevant to thespecific research proposal should also be consulted, such as Chapter 9 concerningresearch involving Aboriginal peoples or Chapter 11 on clinical trials. This chapterdoes not reiterate guidance set out in earlier chapters. Rather, it focuses on issuesthat arise specifically in the context of human genetic research and provides guidancefor managing information revealed through genetic research, provision of geneticcounselling, participation of families, communities and groups in genetic research,banking of human biological materials, and research involving gene transfer.

B. Plans for Managing Information Revealed through Genetic Research

Article 13.2 Researchers conducting genetic research shall:(a) in their research proposal, develop a plan for managing information that may

be revealed through their genetic research;(b) submit their plan to the REB; and(c) advise prospective participants of the plan for managing information revealed

through the research.

Application The types of information that may be revealed through genetic research – and theimplications of this information for participants and their biological relatives –require that researchers and REBs ensure that an appropriate plan is in place formanaging information. In some cases, genetic research may reveal known gene-disease associations or other information, including incidental findings, that maybe clinically relevant for individuals (or their biological relatives) in treating oralleviating health conditions or risks. In other cases, research may revealinformation that is inconclusive in its scientific, clinical or other implications.Genetic research may also reveal information about family relationships, includingadoption and non-paternity.

This range of information varies in its possible implications for individuals. Insome cases, follow-up clinical testing and counselling may be recommended. Infor-mation may also have implications for biological relatives and may raise disclosureconsiderations, as discussed in Article 13.3(b). Genetic information may also affecteligibility for employment or insurance if, for example, an individual who acquiresgenetic information is required to disclose disease predisposition risks to employersor insurers.


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The plan for managing information shall take into account factors such as clinicalrelevance, risks and potential benefits for participants and others who may beaffected. Plans may include sharing individual findings with participants, ornotification of general, non-identifiable research results through newsletters,websites or other means. In regard to release or publication of research findings,the provisions of Chapter 5 apply.

Article 13.3 Where researchers plan to share findings with individuals, researchers shall provideparticipants with an opportunity to:(a) make informed choices about whether they wish to receive information about

themselves; and(b) express preferences about whether information will be shared with biological

relatives, or others with whom the participants have a family, community orgroup relationship.

Application The core principles on which this Policy is based emphasize autonomous choicesregarding research participation. Researchers shall explain to participants the typesof findings that may be revealed (as discussed in the Application of Article 13.2),and the potential implications of these findings, to permit participants to makeinformed choices about whether or not to receive information. Since the right toprivacy includes a right not to know, researchers shall give participants options forreceiving or refusing different types of information.

Where individual findings will be shared with participants, researchers must de-velop appropriate procedures for communicating findings in accordance with theparticipant’s preferences or instructions. These procedures shall be clearly describedin the researcher’s plan. This may include direct communication of findings to theparticipant, or communication to a specified health care provider or other party au-thorized to receive the information. As discussed below, sharing research findingswith individuals may give rise to a need for genetic counselling.

Participants in genetic research shall have an opportunity to express their prefer-ences about the sharing of information with relatives or others. These preferencesmay be subject to overriding considerations that may warrant disclosure of infor-mation to relatives in exceptional circumstances (e.g., if genetic research revealsinformation about a serious or life-threatening condition that can be prevented ortreated through intervention). Articles 5.1 and 5.2 provide guidance on researchers’ethical duty of confidentiality, and situations where researchers may have a require-ment to disclose information to third parties.

Chapter 5 also requires researchers to provide details to the REB regarding theirproposed measures for safeguarding information throughout its life cycle, includ-ing dissemination, and to guard against risks of re-identification. Funders ofhuman genomics research may have policies requiring researchers to make


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genome sequence data publicly accessible. Where such policies apply, researchersmust advise the REB and participants of data-sharing requirements, and measuresfor protection of personal information (see Articles 5.2 and 5.3 for further guid-ance). Publication of aggregated data from genome-wide association studies hasraised concerns about individual re-identification.1 This underscores the need forresearchers and REBs to ensure that measures for safeguarding information areresponsive to risks that arise from continuing advances in genetic research anddata linkage.

C. Genetic Counselling

Article 13.4 Where researchers plan to share results of genetic research with participants, theresearch proposal should make genetic counselling available at that time, whereappropriate.

Application Where the plan for managing information revealed in genetic research involvessharing individual findings with participants, genetic counselling may be requiredto explain the meaning and implications of the information. For example, geneticcounselling can help explain the clinical significance of the information, whetherhealth care interventions or lifestyle changes are recommended, and any implica-tions of the information for biological relatives. Researchers should explain differ-ences between genetic testing in a research context and testing in a clinical context.Clinical genetic testing may be needed to clarify or confirm findings obtained inresearch. Where researchers share information with biological relatives or otherfamily, community or group members, genetic counselling should be made avail-able to them as well as the participants. The counselling service provider must havethe appropriate experience or training to provide genetic counselling, but need notnecessarily hold a diploma, degree or professional designation in genetic coun-selling.

D. Genetic Research Involving Families

Article 13.5 Researchers who seek to recruit members of a family to participate in genetic re-search shall:

(a) ensure recruitment processes respect privacy and other personal interests offamily members; and

(b) seek consent from individual family members.

Application Recruitment of members of a family may take place in various ways: through (a)the researcher, (b) an individual participant, or (c) a third party on behalf of anindividual participant. A family group, such as parents and a child, or several adultsiblings, may all receive an invitation at the same time from the researcher toparticipate in genetic research. Alternatively, researchers may seek permission froman individual participant to contact family members to invite participation. It maybe preferable for the participant to make initial contact with the family member, in


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order to respect privacy interests or known sensitivities. The participant may preferto identify a third party to inform family members about the opportunity toparticipate in genetic research. However, an approach by someone in a position ofauthority over family members may raise concerns about undue influence ormanipulation. Refer to Chapter 3 for further guidance in regard to the voluntarinessof consent.

Family members may have conflicting views about participation in research, andsome may have specific sensitivities or objections. Researchers should recognizethe potential for conflict within families and be respectful of any known sensitivities.Where researchers seek participation from children or other members of a familywho may lack decision-making capacity, the applicable provisions in Chapter 3shall be followed.

E. Genetic Research Involving Communities and Groups

Article 13.6 Where researchers intend to recruit participants for genetic research based on theirmembership in specific communities or groups, it may be appropriate for re-searchers to discuss the research with community or group members, and/or theirleaders, in addition to seeking consent from individual participants. In these cases,researchers shall provide details to the REB about their proposed methods for en-gaging in discussion.

Application Some genetic research seeks to explore genetic variations within specific commu-nities or groups. Such research may raise ethical concerns regarding stigmatization,unfair or inequitable treatment, and social disruption in communities or groups –especially if individual members disagree about participation in research. Discussionwith formal or informal leaders or other members of the community or group maybe appropriate. This determination will depend on factors such as: the objectivesof the proposed research (in particular, the extent to which membership in, orcharacteristics of, the community or group are a key aspect of the research); therisks and potential benefits of the research to the community or group; the natureof the community or group from which participants will be recruited; and thecommunity’s or group’s organizational structure.Individuals within a community or group may have conflicting views about par-ticipation in research, including disagreements between leaders and members. Suchconflicts may involve attempts by some to influence or coerce choices of othersabout whether to participate in research. Researchers should recognize the potentialfor conflict within communities or groups, and ensure that consent and discussionprocesses facilitate free and informed decisions by individual members. Refer toChapter 3 for further guidance in regard to voluntariness of consent.Researchers who propose to conduct genetic research involving Aboriginalparticipants or communities, or to use human biological materials that areidentifiable as originating from Aboriginal peoples, should refer to Chapter 9 forfurther guidance.

F. Genetic Material Banks

Article 13.7 (a) Researchers who propose research involving the collection and banking ofgenetic material shall indicate in their research proposal, and in the informationthey provide to prospective participants, how they plan to address the associatedethical issues, including confidentiality, privacy, storage, use of the data andresults, possibility of commercialization of research findings and withdrawalby participants as well as future contact of participants, families, communitiesand groups.

(b) Researchers who propose research involving the secondary use of previouslycollected and banked genetic material shall, likewise, indicate in their researchproposal how they plan to address associated ethical issues.

Application Collection of human biological materials including genetic materials, and theirretention in biobanks provides an increasingly important research resource. Guid-ance for research involving human biological materials (see Chapter 12) applies tobanking of genetic material. Chapter 12, Section D, provides guidance for the cre-ation of biobanks of genetic material, and Section C addresses access to, and useof, previously collected genetic material. Researchers who intend to bank geneticmaterial shall inform participants of the potential for secondary use. See Chapter5 for guidance regarding secondary use.

G. Gene Transfer

Guidance set out in Chapter 11 applies to clinical trial research involving gene transfer, and Article12.9 is applicable to gene transfer in utero. In the context of gene transfer research, researchersand REBs shall pay careful attention to the need to assess safety, minimize risk, and minimizetherapeutic misconception (see Chapter 11, Section C). Researchers have obligations to share withparticipants new information that may be relevant to ongoing consent, and to follow up with formerparticipants to inform them of issues that may affect their welfare.

Gene alteration involves the transfer of genes into cells to induce an altered capacity of the cell.Viruses are commonly used vectors (carriers) to introduce the gene into the host genome. Genealteration is irreversible – the cell and its descendants are forever altered and introduced changescannot be removed. The possible use of germ line alteration implies changes that could betransmitted to future generations.

Gene transfer research that involves alteration of human germ line cells is governed in Canada bythe Assisted Human Reproduction Act2 and its Regulations. Researchers should be aware of howthis law applies to their work, such as the Act’s prohibition on knowingly altering the genome ofa cell of a human being, or in vitro embryo, such that the alteration is capable of being transmittedto descendants.


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The special circumstances of gene transfer must be explained to prospective participants (orauthorized third parties) during the consent process. This includes providing information aboutuncertain and potentially latent risks of gene transfer, and any processes for long-term follow-upof participants. Guidance regarding inclusion in research (see Chapter 4) should be followed wheregene transfer research involves children, or others who lack the capacity to decide for themselves.

Endnotes

1 In 2008, the U.S. National Institutes of Health amended its policy on publication of and access to datafrom genome-wide association studies. See National Institutes of Health, Modifications to Genome-WideAssociation Studies (GWAS) Data Access, August 28, 2008.

2 Assisted Human Reproduction Act (2004, c. 2).

Reference



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Glossary

This glossary is intended to assist readers in their understanding of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS), also referred to as “the Policy.” Definitions that have been provided in the main text of the Policy are also repeated here. Additional terms are defined in accordance with the purposes of the Policy.

Aboriginal peoples – Persons of Indian (First Nations), Inuit, or Métis descent, regardless of where theyreside and whether or not their names appear on an official register. In the international context, the termcomparable to Aboriginal peoples is Indigenous peoples.

Academic freedom – The collective freedom of faculty and students to conduct research, and to disseminateideas or facts without religious, political, or institutional restrictions. It includes freedom of inquiry, freedomto challenge conventional thought, freedom to express one’s opinion about the institution, its administration,or the system in which one works, and freedom from institutional censorship.

Ad hoc advisor – A person with relevant and competent knowledge and expertise consulted by a researchethics board for a specific research ethics review, and for the duration of that review. The ad hoc advisor isnot a member of the research ethics board.

Agencies, the – Canada’s three federal research agencies: the Canadian Institutes of Health Research(CIHR); the Natural Sciences and Engineering Research Council of Canada (NSERC); and the SocialSciences and Humanities Research Council of Canada (SSHRC).

Agreement – Agreement on the Administration of Agency Grants and Awards by Research Institutions.

Appeal – A process that allows a researcher to request a review of a research ethics board (REB) decisionwhen, after reconsideration, the REB has refused ethics approval of the research.

Appeal mechanism – A procedure established by an institution to promptly handle a researcher’s appealof a research ethics board (REB) decision. An ad hoc or permanent appeal committee, which reflects arange of expertise and knowledge similar to that of the REB, is established or appointed by the sameauthority that established the REB.

Authorized third party – Any person with the necessary legal authority to make decisions on behalf of aprospective participant who lacks the capacity to decide whether or not to participate, or to continue toparticipate, in a particular research project. In other policies/guidance they are also known as “authorizedthird party decision makers.”

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Autonomy – The capacity to understand information and to be able to act on it voluntarily; the ability ofindividuals to use their own judgment to make decisions about their own actions, such as whether or notto participate in research.

Biobank – A collection of human biological materials. It may also include associated information aboutindividuals from whom biological materials were collected.

Clinical equipoise – The existence of a genuine uncertainty on the part of the relevant expert communityabout what therapy or therapies are most effective for a given condition.

Clinical trial – Any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes.

Coercion – An extreme form of undue influence, involving a threat of harm or punishment for failure toparticipate in research. See “Undue influence.”

Collaborative research – Research that involves the cooperation of researchers, institutions, organizationsand/or communities, each bringing distinct expertise to a project, and that is characterized by respectfulrelationships. See “Community-based research” and “Participatory research.”

Community – A group of people with a shared identity or interest that has the capacity to act or expressitself as a collective. A community may be territorial, organizational, or a community of interest.

Community-based research – Research conducted at a community site that focuses not only on individualsbut on the community itself. Community-based research may be initiated by the community independentlyor in collaboration with a researcher. See “Collaborative research” and “Participatory research.”

Community engagement – A process that establishes an interaction between a researcher (or a researchteam) and a community with regard to a research project. It signifies the intent of forming a collaborativerelationship between researchers and communities, although the degree of collaboration may vary depend-ing on the community context and the nature of the research.

Concern for Welfare – A core principle of this Policy that requires researchers and research ethics boardsto aim to protect the welfare of participants, and, in some circumstances, to promote that welfare in viewof any foreseeable risks associated with the research. See “Risk” and “Welfare.”

Confidentiality – An ethical and/or legal responsibility of individuals or organizations to safeguard informa-tion entrusted to them, from unauthorized access, use, disclosure, modification, loss or theft.

Conflict of interest – The incompatibility of two or more duties, responsibilities, or interests (personal orprofessional) of an individual or institution as they relate to the ethical conduct of research, such that onecannot be fulfilled without compromising another.

Consent – An indication of agreement by an individual to become a participant in a research project.Throughout this Policy, the term “consent” means “free (also referred to as voluntary), informed and on-going consent.”

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Continuing research ethics review (also referred to as “Continuing ethics review”) – Any review ofongoing research conducted by a research ethics board (REB) occurring after the date of initial REBapproval and continuing throughout the life of the project to ensure that all stages of a research project areethically acceptable in accordance with the principles in the Policy.

Core principles – The three core principles of the Policy that together express the overarching value of re-spect for human dignity: Respect for Persons, Concern for Welfare, and Justice. See “Respect for Persons,”“Concern for Welfare” and “Justice.”

Creative practice – A process through which an artist makes or interprets a work, or works, of art. It mayalso include a study of the process of how a work of art is generated.

Critical inquiry – The analysis of social structures or activities, public policies, or other social phenomenafor research purposes.

Cultural heritage – A dynamic concept which includes, but is not limited to, First Nations, Inuit and Métispeoples’ relations with particular territories, material objects, traditional knowledge and skills, and intan-gibles that are transmitted from one generation to the next, such as sacred narratives, customs, representa-tions or practices.

Cyber-material – Documents, images, audio or video recordings, records, performances, or on-line archivalmaterials available in digital form on the Internet.

Data linkage – The merging or analysis of two or more separate data sets (e.g. health information andeducation information about the same individuals) for research purposes. See also “Data set.”

Data safety monitoring board – A multi-disciplinary, expert advisory group established by a researchsponsor, that is responsible for safeguarding the interests of participants by reviewing emerging data,assessing the safety and efficacy of clinical trial procedures, and monitoring the overall conduct of a trial.

Data set – A collection of information to be used for research purposes, including human biologicalmaterials.

Data steward – Data stewards are responsible for data definition (i.e., defining the characteristics of theelements in a database) and access authorization, particularly data access and disclosure to third parties.

Debriefing – The full disclosure of the research purpose and other pertinent information to participantswho have been involved in research employing partial disclosure or deception. Debriefing is typically doneafter participation has ended, but may be done at any time during the study.

Decision-making capacity – The ability of prospective or actual participants to understand relevant infor-mation presented (e.g., purpose of the research, foreseeable risks, and potential benefits), and to appreciatethe potential consequences of any decision they make based upon this information.

Delegated research ethics board (REB) review – The level of REB review assigned to minimal riskresearch projects. Delegated reviewers are selected from among the REB membership, with the exceptionof the ethics review of student course-based research which can be reviewed by delegates from the student’s

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department, faculty, or an equivalent level. Delegated reviewers who are non-members or non-votingmembers of the REB must have experience, expertise and knowledge comparable to what is expected ofan REB member.

Differentiation – The process by which cells acquire new characteristics and form more specialized cell types.

Disciplined inquiry – an inquiry that is conducted with the expectation that the method, results, andconclusions will be able to withstand the scrutiny of the relevant research community.

Embryo – A human organism during the first 56 days of its development following fertilization or creation,excluding any time during which its development has been suspended. It also includes any cell derivedfrom such an organism that is used for the purpose of creating a human being.

Embryonic germ (EG) cells – Pluripotent stem cells derived from the cells in the fetal gonad that wouldnormally develop into mature gametes.

Embryonic stem (ES) cell – A cell derived from the inner cell mass of developing blastocysts. An embry-onic stem cell is self-renewing (can replicate itself) and pluripotent.

Embryonic stem cell line – An embryonic stem cell line is derived from one embryo that has been prop-agated indefinitely in culture.

Emergency preparedness plans – Plans that detail an institution’s policies and procedures for addressingresearch ethics review during public health outbreaks, natural disasters, and other publicly declared emer-gencies. See “Publicly declared emergency.”

Emergent design – A research method in which data collection and analyses can evolve over the courseof a research project in response to what is learned in earlier parts of the study.

Fetal tissue – Membranes, placenta, umbilical cord, amniotic fluid, and other tissue that contains geneticinformation about the fetus.

Fetus – A human organism during the period of its development beginning on the 57th day followingfertilization or creation, excluding any time during which its development has been suspended, and endingat birth.

Full research ethics board (REB) review – The level of REB review assigned to above minimal risk re-search projects. Conducted by the full membership of the research ethics board, it is the default requirementfor the ethics review of research involving humans.

Gamete – The sex cell (sperm or egg). The functional, mature, male gamete is called a “sperm” while thefemale gamete is called the “ovum” or “egg.”

Gender – Gender refers to the socially constructed roles, behaviours, expressions and identities of girls,women, boys, men, and gender diverse people. It influences how people perceive themselves and eachother, how they act and interact, and the distribution of power and resources in society. Gender is usuallyconceptualized as a binary (girl/woman and boy/man) yet there is considerable diversity in how individualsand groups understand, experience, and express it.

Gene alteration – The transfer of genes into cells to induce an altered capacity of the cell.

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Genetic counselling – The explanation of the meaning and implication of information revealed in geneticresearch to a participant by someone with the experience or training to provide the appropriate context andsupport.

Harm – Anything that has a negative effect on participants’ welfare, broadly construed. The nature of theharm may be social, behavioural, psychological, physical or economic. See “Welfare.”

Human biological materials – Tissues, organs, blood, plasma, skin, serum, DNA, RNA, proteins, cells,hair, nail clippings, urine, saliva, and other body fluids. The term also includes materials related to humanreproduction, including embryos, fetuses, fetal tissues and human reproductive materials.

Anonymized human biological materials – The materials are irrevocably stripped of direct iden-tifiers, a code is not kept to allow future re-linkage, and risk of re-identification of individuals fromremaining indirect identifiers is low or very low.

Anonymous human biological materials – The materials never had identifiers attached to themand risk of identification of individuals is low or very low.

Coded human biological materials – Direct identifiers are removed from the materials andreplaced with a code. Depending on access to the code, it may be possible to re-identify specificindividuals (e.g. a principal investigator retains a key that links the coded material with a specificindividual if re-linkage is necessary).

Identified human biological materials – The materials are labelled with a direct identifier (e.g.name, personal health number). Materials and any associated information are directly traceableback to a specific individual.

Human embryonic stem cell (hESC) – An embryonic stem cell derived from a human embryo.

Human genetic research – The study of genetic factors responsible for human traits and the interaction ofthose factors with each other, and with the environment.

Human participant – See “Participant.”

Human reproductive materials – A sperm, ovum, or other human cell, or a human gene, including a partof any of them.

Identifiable human biological materials – Human biological materials that may reasonably be expectedto identify an individual, alone or in combination with other available information.

Identifiable information – Information that may reasonably be expected to identify an individual, aloneor in combination with other available information. Also referred to as “personal information.”

Impracticable – Incapable of being put into practice due to a degree of hardship or onerousness that jeop-ardizes the conduct of the research; it does not mean mere inconvenience.

Incentive – Anything offered to participants, monetary or otherwise, to encourage participation in research.

Incidental findings – Unanticipated discoveries made in the course of research that are outside the scopeof the research.

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Indigenous knowledge – See “Traditional knowledge.”

Indigenous peoples – See “Aboriginal peoples.”

Induced pluripotent stem cell (iPSC) – A type of pluripotent stem cell, similar to an embryonic stemcell, formed by the introduction of certain embryonic genes into a somatic cell.

Information (Types)

Anonymized information – The information is irrevocably stripped of direct identifiers, a code isnot kept to allow future re-linkage, and risk of re-identification of individuals from remaining in-direct identifiers is low or very low.

Anonymous information – The information never had identifiers associated with it (e.g., anony-mous surveys) and risk of identification of individuals is low or very low.

Coded information – Direct identifiers are removed from the information and replaced with acode. Depending on access to the code, it may be possible to re-identify specific participants (e.g.,the principal investigator retains a list that links the participants’ code names with their actual nameso data can be re-linked if necessary).

Directly identifying information – The information identifies a specific individual through directidentifiers (e.g., name, social insurance number, personal health number).

Indirectly identifying information – The information can reasonably be expected to identify anindividual through a combination of indirect identifiers (e.g., date of birth, place of residence, orunique personal characteristic).

Institutional conflicts of interest – An incompatibility between two or more substantial institutionalobligations that cannot be adequately fulfilled without compromising one or another of the obligations.

Institutions – The universities, hospitals, colleges, research institutes, centres and other organizationseligible to receive and manage Agency grant funds on behalf of the grant holders and the Agencies.

Intermediary – An individual with the necessary language skills to ensure effective communicationbetween the research team and participants, should any language barriers exist.

Justice – A core principle of this Policy that refers to the obligation to treat people fairly and equitably.Fairness entails treating all people with equal respect and concern. Equity requires distributing the benefitsand burdens of research participation in such a way that no segment of the population is unduly burdenedby the harms of research or denied the benefits of the knowledge generated from it.

Medical device trials – Clinical trials that test the safety and/or efficacy of one or more instruments usedin the prevention, diagnosis, mitigation, or treatment of a disease or abnormal physical condition or therestoration, correction or modification of body function or structure.

Medical emergency – A situation in which one or more individuals requires urgent medical care.

Minimal risk research – Research in which the probability and magnitude of possible harms implied byparticipation in the research is no greater than those encountered by participants in the aspects of theireveryday life that relate to the research.

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Multi-jurisdictional research – Research involving multiple institutions and/or multiple REBs. It is notintended to apply to ethics review mechanisms for research involving multiple REBs within the jurisdictionor under the auspices of a single institution.

Natural Health Product (NHP) Trial – A clinical trial testing the safety and/or efficacy of one or morenatural health products. The term natural health product is used to describe substances such as vitaminsand minerals, herbal medicines, homeopathic preparations, energy drinks, probiotics, and many alternativeand traditional medicines.

Observational research – The study of behaviour in a natural environment in which people involved intheir normal activities are observed whether with or without their knowledge. This term does not includeobservational methods used in epidemiological research.

Ongoing research – Research that has received REB approval and has not yet been completed.

Participant – An individual whose data, or responses to interventions, stimuli, or questions by a researcherare relevant to answering a research question; also referred to as “human participant,” and in otherpolicies/guidance as “subject” or “research subject.”

Participatory research – Research that includes the active involvement of those who are the subject of theresearch. Participatory research is usually action-oriented, where those involved in the research processcollaborate to define the research project, collect and analyze the data, produce a final product and act onthe results. See “Community-based research” and “Collaborative research.”

Personal information – Identifiable information about an individual. See “Identifiable information.”

Pharmaceutical trial – A clinical trial designed to test the safety and/or efficacy of a pharmaceutical product.

A pharmaceutical product is any chemical substance intended for use in the medical diagnosis,cure, treatment, or prevention of disease, disorders, or other illness.

Placebo-controlled trials – A clinical trial in which the safety or efficacy of one or more interventions arecompared with a placebo control group.

A placebo is an inactive substance or intervention that resembles the comparable active substanceor intervention.

Pluripotent stem cell – A cell that can become all the cell types that are found in an implanted embryo,fetus, or developed organism, but not embryonic components of the trophoblast and placenta. Pluripotentstem cells include embryonic stem cells, induced pluripotent stem cells and embryonic germ cells.

Possible/Impossible – If an action can be done, regardless of the level of difficulty required to do it, it ispossible. If an action cannot be done under any circumstances, it is impossible. For example, it is possibleto offer debriefing to participants who have participated anonymously in an online survey by providingthem with the researchers’ email for the purpose of requesting debriefing information at the point of exitfrom the survey. In the case of secondary use of data or materials that have been stored for decades −without any identifiers or contact information − it is impossible to offer a consent process or a debriefingto the original providers of these data or materials (see Chapter 5, Key Concepts).

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Practicable/Impracticable – An action is practicable if it is possible and it is reasonable to expect theaction to be done. For example, it is practicable to offer consent materials and task instructions in multiplelanguages when members of the desired participant population speak different languages and there is nocommon language understood by all participants. An action is possible but not practicable when circum-stances render a possible action unreasonably difficult to execute, or, the action will jeopardize the abilityof the researcher to address the research question. For example, in a study examining the effect of twotypes of exit signage (alternated daily for two weeks) on crowd behaviour in a stadium, it would be im-practicable to seek prior consent without affecting the behaviour under observation. It may be practicableto offer debriefing once the study is concluded, by advertising the availability of information about thestudy to the community that makes use of the stadium.

Principal investigator – The leader of a research team who is responsible for the ethical conduct of theresearch, and for the actions of any member of the research team.

Privacy – An individual’s right to be free from intrusion or interference by others.

Privacy risks – The potential harms that participants, or the groups to which they belong, may experiencefrom the collection, use, and disclosure of personal information for research purposes.

Proportionate approach to research ethics review – The assessment of foreseeable risk to determine thelevel of scrutiny a research proposal will receive (i.e. delegated review for minimal risk research or fullREB review for research above minimal risk), as well as the consideration of foreseeable risks, potentialbenefits, and ethical implications of the research in the context of initial and continuing review.

Psychotherapy trials – A clinical trial testing the safety and/or efficacy of one or more psychotherapeuticapproaches to behavioural disorders or other mental illness.

Publicly available information – Any existing stored documentary material, records or publications, whichmay or may not include identifiable information, and that has no restrictions on its use or distribution, orthat may be released under certain legal conditions.

Publicly declared emergency – An emergency situation which, due to the extraordinary risks it presents,has been proclaimed as such by an authorized public office (in accordance with legislation and/or publicpolicy). Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly, andrequire urgent or quick responses to minimize devastation. Examples include hurricanes and other naturaldisasters, large communicable disease outbreaks, catastrophic civil disorders, bio-hazardous releases, en-vironmental disasters, and humanitarian emergencies.

Qualitative research – An approach that aims to understand how people think about the world and howthey act and behave in it. This approach requires researchers to understand phenomena based on discourse,actions, and documents, and how and why individuals interpret and ascribe meaning to what they say anddo, and to other aspects of the world (including other people) they encounter.

Reciprocal research ethics board (REB) review – An official agreement between two or more institutions,in which they accept, with an agreed level of oversight, the research ethics reviews of each other’s REBs.

Reimbursement – Payment to participants to ensure that they are not put at a direct, or indirect, financial

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disadvantage for the time and inconvenience of participation in research. Direct expenses refer to the costsincurred, and indirect expenses refer to losses that arise, because of research participation.

Research – An undertaking intended to extend knowledge through a disciplined inquiry and/or systematicinvestigation.

Research agreement – A document that serves as a primary means of clarifying and confirming mutualexpectations and, where appropriate, commitments between researchers and communities.

Research directive – Written instructions used to express an individual’s preferences for participation infuture research, in the event that the individual loses decision-making capacity. It is intended to guide theindividual’s authorized third party in deciding whether or not to give substitute consent for the individualto participate in research.

Research ethics board (REB) – A body of researchers, community members, and others with specific ex-pertise (e.g. in ethics, in relevant research disciplines) established by an institution to review the ethicalacceptability of all research involving humans conducted within the institution’s jurisdiction or under itsauspices.

Research ethics education and training – The provision of materials and corresponding instruction byan institution to research ethics board (REB) members or researchers with regard to the core principles andunderstanding of this Policy, basic ethics standards, applicable institutional policies, and legal or regulatoryrequirements. This term also includes an understanding of the role and mandate of REBs and responsibilitiesof REB members.

Research involving partial disclosure or deception – A type of research, in which the participant maynot know that they are part of a project until it is over or is not informed of the true purpose of the researchin advance. See “Debriefing.”

Respect for Persons – A core principle of this Policy that recognizes the intrinsic value of human beingsand the respect and consideration that they are due. It incorporates the dual moral obligations to respectautonomy and to protect those with developing, impaired, or diminished autonomy.

Risk – The possibility of the occurrence of harm. The level of foreseeable risk posed to participants bytheir involvement in research is assessed by considering the magnitude or seriousness of the harm and theprobability that it will occur, whether to participants or to third parties.

Secondary use – The use in research of information or human biological materials originally collected fora purpose other than the current research purpose.

Security – Measures taken to protect information. It includes physical, administrative, and technical safe-guards.

Sex – Refers to a set of biological attributes in humans and animals. It is primarily associated with physicaland physiological features including chromosomes, gene expression, hormone levels and function, andreproductive/sexual anatomy. Sex is usually categorized as male or female but there is variation in thebiological attributes that comprise sex and how those attributes are expressed.

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Shall – Indicates a mandatory provision.

Should – Indicates guidance for the interpretation of the core principles.

Somatic cell – Any body cell other than gametes (egg or sperm); sometimes referred to as "adult" cells.

Somatic (adult) stem cell – A relatively rare undifferentiated cell found in many organs and differentiatedtissues with a limited capacity for both self-renewal (in the laboratory) and differentiation. Such cells varyin their differentiation capacity, but it is usually limited to cell types in the organ of origin. These are stemcells with a more restricted differentiation capacity than pluripotent stem cells.

Stem cell – A cell that has the ability to divide for indefinite periods in culture and to give rise to specialized cells.

Stopping rules – Statistically significant end points and safety considerations for a clinical trial that aredetermined in advance, and, once reached, dictate that the trial must be terminated.

Surgical trials – A clinical trial which compares the safety and/or efficacy of different surgical techniques.

Therapeutic misconception – A misunderstanding, on the part of participants, of the purpose, benefits,and/or risks of clinical trials. Often participants do not understand that research is aimed primarily atproducing knowledge and may not provide any therapeutic benefit to them.

Traditional knowledge – The knowledge held by First Nations, Inuit and Métis peoples, the Aboriginalpeoples of Canada. Traditional knowledge is specific to place, usually transmitted orally, and rooted in theexperience of multiple generations. It is determined by an Aboriginal community’s land, environment,region, culture, and language. It may also include new knowledge transmitted to subsequent generations.

Unanticipated issues – Issues that: occur during the conduct of research; may increase the level of risk toparticipants or have other ethical implications that may affect participants’ welfare; and were not anticipatedby the researcher in the research proposal submitted for research ethics review.

Undue influence – The impact of an unequal power relationship on the voluntariness of consent. This mayoccur when prospective participants are recruited by individuals in a position of authority over them (e.g.doctor/patient, teacher/student, employer/employee). See “Coercion.”

Vulnerability – A diminished ability to fully safeguard one’s own interests in the context of a specificresearch project. This may be caused by limited decision-making capacity or limited access to social goods,such as rights, opportunities and power. Individuals or groups may experience vulnerability to differentdegrees and at different times, depending on their circumstances. See also “Autonomy.”

Welfare – The quality of a person’s experience of life in all its aspects. Welfare consists of the impact onindividuals and/or groups of factors such as their physical, mental and spiritual health, as well as theirphysical, economic and social circumstances.